Reprocessing of contaminated reusable devices with direct contact of pressure waves

ABSTRACT

Reusable instrumentation, such as a medical instrument or tool, is decontaminated by applying pressure waves from multiple shockwave applicators and/or reflectors.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. application Ser. No.17/977,529, filed Oct. 31, 2022, which is a Continuation of U.S.application Ser. No. 17/313,951, filed May 6, 2021, now abandoned, whichclaims the benefit of priority of U.S. Provisional Application No.63/020,987 filed May 6, 2020, the entireties of which are incorporatedherein by reference.

BACKGROUND OF THE INVENTION

An acute respiratory tract infection or disease is usually caused by aninfectious agent, as bacteria, viruses. Lung acute responses can beproduced also by irritant particles that are voluntary or accidentallyingested. Although the spectrum of symptoms of acute respiratoryinfection may vary, the onset of symptoms is typically rapid, rangingfrom hours to days after infection. Symptoms include fever, cough, sorethroat, inflammation of the mucous membrane in the nose, shortness ofbreath, wheezing, or difficulty in breathing.

Bacteria can cause pneumonia or tuberculosis. The most common causes ofbacterial lung infections in normal hosts include Streptococcuspneumoniae, Haemophilus species, Staphylococcus aureus and Mycobacteriumtuberculosis.

The most known viral pathogens that affect lungs include influenzavirus, parainfluenza virus, rhinovirus, respiratory syncytial virus(RSV) and severe acute respiratory syndrome coronavirus (SARS-CoV orCOVID-19).

Fungus infections are also possible for the lungs. Aspergillosis isinfection, usually of the lungs, caused by the fungus Aspergillus. Aball of fungus fibers, blood clots, and white blood cells may form inthe lungs or sinuses. People may have no symptoms or may cough up bloodor have a fever, chest pain, and difficulty breathing.

Acute respiratory infections are the leading cause of morbidity andmortality from infectious disease worldwide, particularly affecting theyoungest and oldest people, as shown by the recent COVID-19 globalpandemic or by mixed viral-bacterial infections. Although the knowledgeof transmission modes is ever evolving, the current evidence indicatesthat the primary mode of transmission of most acute respiratory diseasesis through droplets, direct contact (including hand contaminationfollowed by self-inoculation) or infectious respiratory aerosols. Ingeneral, such infections can be contagious and spread rapidly.

Bronchitis is an acute inflammation of the bronchial lining. It iscommonly related to cigarette smoking but is also triggered byenvironmental irritants such as chemical vapors, exhaust fumes orpesticides. In response to the inflammation, excess mucus is produced.This can block the small airways and reduce respiratory efficiency, forexample, in chronic airways obstruction. Over-production of mucus leadsto frequent coughing, which further irritates the tissues and causeseven more mucus production.

One of the most common chronic afflictions of the lungs is the chronicobstructive pulmonary disease (COPD), which is a lung diseasecharacterized by chronic obstruction of lung airflow that interfereswith normal breathing. The more familiar terms ‘chronic bronchitis’ and‘emphysema’ are no longer used, but are now included within the COPDdiagnosis. Chronic bronchitis is inflammation of the lining of thebronchial tubes, which carry air to and from the air sacs (alveoli) ofthe lungs. It is characterized by daily cough and mucus (sputum)production. Emphysema is a condition in which the alveoli at the end ofthe smallest air passages (bronchioles) of the lungs are destroyed as aresult of damaging exposure to cigarette smoke and other irritatinggases and particulate matter.

Another pulmonary disease that can turn chronic is the idiopathicpulmonary fibrosis (IPF). This disease is a progressive interstitiallung disease, which is proposed to develop as a result of overexuberantremodeling following pulmonary epithelial damage, and which ischaracterized by chronic inflammation, alveolar epithelial hyperplasia,and deposition of extracellular matrix leading to development of apermanent “scar”.

When any of the above-mentioned lung diseases reach a phase of severoxygenation impairment (pulmonary insufficiency) ventilators orrespirators devices/system are used. A ventilator or a respirator is amachine that helps a patient breathe by blowing oxygen into the lungsand removing carbon dioxide out of the lungs. The ventilator is attachedto a breathing tube at one end that is placed in the person's mouth orin an opening through the neck into the windpipe (trachea), which iscalled a tracheostomy. If mucus collects, the lungs do not get enoughoxygen. The mucus can also lead to pneumonia. To get rid of the mucus, aprocedure called suctioning is needed. This is done by inserting a smallthin tube into the person's mouth or neck opening to vacuum out themucus. Such devices or systems have reusable parts that will requirecleaning and high-level disinfection in between treatment of differentpatients. That is warranted by the contamination with individualbacteria and viruses, or sometimes by the formation of biofilms. Thebiofilms can comprise one or more microorganisms such for example asbacteria, fungi, protozoa, archaea, algae and/or microscopic parasitesas viruses.

Uniform and standardized recommendations for reprocessing of anestheticand ventilatory equipment are still lacking. The uncertainty in thisfield is emphasized by the various methods that are described in theliterature, which include pasteurization, immersion baths, formaldehydecabinets, automated washers/disinfectors and sterilization procedureslike autoclaving, ethylene oxide and gaseous formaldehyde. Based on theclassification of anesthetic and ventilatory equipment as semi-criticalitems, high level disinfection must be regarded as the appropriatedecontamination procedure. The high-level disinfection procedures lackan integrated and all-inclusive reprocessing cycle, which consists ofcleaning, disinfection, rinsing and drying. Also, there are automatedwashers/disinfectors—either based on hot water disinfection orchemo-thermic processing that are used for a standardized reprocessingof anesthetic and ventilatory equipment.

Besides ventilators and respirators, other medical systems that can beheavily contaminated during usage are endoscopes, arthroscopes,laparoscopes, bronchoscopes, nasopharygoscopes, duodenoscopes,cystoscopes, sigmoidoscopes, hemodialysis units, dental instruments,vaginal probes, rectal probes, pharyngeal probes, and cryosurgicalinstrumentation. The dental instruments, vaginal probes, rectal probes,pharyngeal probes, and cryosurgical instrumentation are usuallysterilized in between usage and other systems as some of thehemodialysis units use disposable elements. The endoscopes,arthroscopes, laparoscopes, bronchoscopes, nasopharygoscopes,duodenoscopes, sigmoidoscopes and cystoscopes represent complex reusableinstrumentation. Such instruments can be used anywhere from 300 to 1,200times a year. It is estimated that in the U.S. alone 15 million flexibleendoscope procedures are performed annually. Procedures are performed ina variety of settings, from a doctor's office to a hospital surgicalsuite. The methods employed to clean and disinfect these flexibleendoscopes are also very diverse. A key concern, no matter where theseprocedures are done, is how clean these scopes are after reprocessing.With the prevalence of highly contagious diseases such as Hepatitis Band Acquired Immune Deficiency Syndrome (AIDS), effective cleaning,high-level disinfection or sterilization of such reusable medicaldevices it becomes mandatory to prevent infections. Due to theircomplexity, flexible endoscopes generally cannot be steam sterilized.Low temperature, highly specialized devices or methods must be employedto clean and disinfect these instruments.

There is a classification system first proposed by Dr. E. H. Spauldingthat divides medical devices into categories based on the risk ofinfection involved with their use. This classification system is widelyaccepted and is used by the U.S. Food and Drug Administration (FDA), theCenters for Disease Control and Prevention (CDC), epidemiologists,microbiologists, and professional medical organizations to helpdetermine the degree of disinfection or sterilization required forvarious medical devices. Three categories of medical devices and theirassociated level of disinfection are recognized:

-   -   Critical: A device that enters normally sterile tissue or the        vascular system. Such devices should be sterilized, defined as        the destruction of all microbial life. Examples include        endoscopes used in sterile settings such as laparoscopic        endoscopy and endoscopic accessories such as biopsy forceps and        sphincterotomes.    -   Semi critical: A device that comes into contact with intact        mucous membranes and does not ordinarily penetrate sterile        tissue. These devices (e.g., gastrointestinal endoscopes) should        receive at least high-level disinfection (HLD), defined as the        destruction of all vegetative microorganisms, mycobacteria,        small or nonlipid viruses, medium or lipid viruses, fungal        spores, and some, but not all, bacterial spores.    -   Noncritical: Devices that do not ordinarily touch the patient or        touch only intact skin, such as stethoscopes or patient carts.        These items may be cleaned by low-level Disinfection

Semi-critical disinfection involves disinfection of items that come incontact with mucous membranes and intact skin, but not with internal,natural sterile areas of the body. Cleaning of semi-criticalitems/equipment is an important step in the disinfection process toensure the disinfecting of the items/equipment will be successful. Thecleaning process must be thoroughly because organic material may protectmicroorganisms from the disinfection process and should take placebetween each device/equipment usage. In general, these systems will bedisassembled (as appropriate) and thoroughly cleaned. Semi-criticalitems may be contaminated with dried or wet sputum and/or blood andshould be cleaned using a detergent, rinsed, and dried prior to be usedagain. The high-level disinfection consists of immersing the device orequipment or system in a biocide solution for 5-minutes. Afterwards, thedevice or equipment or system should be removed from the solution andthoroughly rinsed using sterile water when practical, otherwise potablewater is acceptable for semi-critical devices or equipment or systemsnot intended for use on immunocompromised patients or potentiallyimmunocompromised patients. The device or equipment or system should betotally immersed for a minimum of 1-minute repeating this step formultiple consecutive times. Then all lumens must be manually flushed.Following the rinsing step, the device or equipment or system should bedried and stored in a suitable container for future use.

At this time, the FDA-cleared and marketed formulations of chemicalsused during high-level disinfections include: ≥2.4% glutaraldehyde,0.55% ortho-phthalaldehyde (OPA), 0.95% glutaraldehyde with 1.64%phenol/phenate, 7.35% hydrogen peroxide with 0.23% peracetic acid, 1.0%hydrogen peroxide with 0.08% peracetic acid, and 7.5% hydrogen peroxide.These products have excellent antimicrobial activity; however, someoxidizing chemicals (e.g., 7.5% hydrogen peroxide, and 1.0% hydrogenperoxide with 0.08% peracetic acid) reportedly have caused cosmetic andfunctional damage to endoscopes. Ethylene Oxide (EtO) sterilization offlexible endoscopes is infrequent because it requires a lengthyprocessing and aeration time (e.g., 12 hours), is costly, inefficient,cannot sterilize residual gross soil, affects endoscope durability, andis a potential hazard to staff and patients. The two products mostcommonly used for reprocessing endoscopes in the United States areglutaraldehyde and an automated, liquid chemical sterilization processthat uses peracetic acid. The FDA-cleared labels for high-leveldisinfection with >2% glutaraldehyde at 25° C. range from 20-90 minutes.Clearly, other new or validated low-temperature reprocessingtechnologies and/or endoscope designs are needed.

There are also new high-level disinfectants and agent specificmachines/reprocessors in the marketplace. If a reprocessor is used, theendoscope and endoscope components are placed in the reprocessor and allchannel connectors should be attached according to the reprocessormanufacturers' instructions to ensure exposure of all internal surfaceswith the high-level disinfectant solution. After high leveldisinfection, the endoscopes' channels are rinsed and flushed withsterile or filtered water to remove the disinfectant solution. The rinsewater is discarded after each use/cycle. Then the endoscope's channelsare flushed with 70% to 90% ethyl or isopropyl alcohol and dried usingfiltered forced air. The final drying steps greatly reduce the risk ofremaining pathogens and the possibility of recontamination of theendoscope by waterborne microorganisms.

For hemodialysis units, the noncritical surfaces (e.g., dialysis bed orchair, countertops, external surfaces of dialysis machines, andequipment as scissors, hemostats, clamps, blood pressure cuffs,stethoscopes) should be disinfected with an EPA (EnvironmentalProtection Agency) registered disinfectant unless the item is visiblycontaminated with blood. When blood is present a tuberculocidal agent ora disinfectant with specific label claims for hepatitis virus and HIV ora 1:100 dilution of a hypochlorite solution is used. This procedureremoves soil on a regular basis and maintains an environment that isconsistent with good patient care. Hemodialysis systems usually aredisinfected by chlorine-based disinfectants (e.g., sodium hypochlorite),aqueous formaldehyde, heat pasteurization, ozone, or peracetic acid.However, new methods are needed, which can eliminate the use of chemicaldisinfectants that have significant environmental impact or usinglong-cycles of high temperature (pasteurization) that reducessignificant the longevity of dialysis components exposed to it.

SUMMARY OF THE INVENTION

In the last decades, there were new types of viruses that producedsevere infections in humans (Severe Acute Respiratory Syndrome(SARS-CoV) in 2003, porcine flu in 2009, Middle East RespiratorySyndrome (MERS) in 2015, and lately the Corona Virus Disease (COVID-19)in 2019/2020) or seasonal re-occurrence of certain diseases as flu orinfluenza. There are also known super virulent viruses that produce on alarge-scale hepatitis infection on global population, or the humanimmunodeficiency virus (HIV) that killed many people or requiresextensive treatments to keep it in check. Other viral infections asEbola, Dengue, West Nile, Zika and Chikungunya, to name a few, arestarted to pose significant threat to human population. Besides theinfections produces by viruses, the bacterial or fungal infections canalso pose significant strain on the medical system and the health ofhumans. The mouth, eyes, nasal cavity, throat, lungs, stomach,intestines are susceptible areas and organs to such infections, sincethere is a conduit or conduits linked to them that gives a directpathways access for the external pathogens to penetrate inside the humanor animal body. These infections can be easily transmitted throughbodily fluids, and during exploratory or treatment procedures involvingendoscopes or treatments using ventilators or hemodialysis systems, ifthe reprocessing of these medical devices/systems or subassembly orparts or accessories is done improperly or is not sufficient to kill allthe germs.

The actual practices used to clean and disinfect reusable parts orsubassembly or devices/systems are not uniformly defined and prone tomistakes, which can result in the use of contaminated medical systems.The contamination is in the form of planktonic bacteria, virus spores,fungi, and biofilms. Furthermore, the actual practices are relyingheavily on chemicals and energy intensive methods that have importantenvironmental consequences, and require substantial protection equipmentfor the health personnel responsible for cleaning and decontamination,which generates extra waste and drive the costs up. There are electronicpumps that can be used to irrigate the endoscopes that are used whenrinsing the lumens of the endoscopes prior to manual or semi-manualhigh-level disinfection. Failure to rinse the endoscope completely mayreduce the effectiveness of the disinfection cycle. Even more, thecleaning and decontamination processes are time consuming, tedious, andrequire numerous subsequent steps, which makes the personnel performingthese processes susceptible to miss or skip some of the steps. This cancontribute to improper cleaning and decontamination of these reusableparts or subassembly or devices/systems, which can ultimately generateinfections with significant health consequences and even death.

For the manual cleaning and disinfection of endoscopes, ventilators' orhemodialysis units' tubing or specific components, usually appropriatelysized cleaning brushes and specific biocide solutions are used to removeand flush the biological and pathogenic material from the lumens of theendoscopes or the tubing or specific components used for ventilators orhemodialysis units. The usage of an appropriately sized cleaning brusheswithout kinks and with soft bristles is needed to have contact on theside walls of the endoscopes' suction/biopsy channels or ventilators orhemodialysis' tubing so that debris can be cleared. Slow movementsinserting the brush and friction while removing the brush will loosendebris that may be on both proximal and distal sides of the channels. Ifthe brush is too small, there will be little contact with the debris orchannel wall. If the brush is too large, can get lodged in the channeland the bristles may be deflected upward as the brush travels thechannel merely swiping the sides of the channel. The condition of thebrush must be assured to be safe. If the protective tip is missing, thecoiling unbraided, some bristles absent, or the delivery tube (whethermetal or plastic) kinked, the brush may tear a hole as it travels downthe channel lumen. Because this occurs after the leakage test has beenperformed, the hole may go unnoticed and the subsequent patient beexposed to bio-burden and cleaning chemical retained in the scope. Thereis no maximal number of times each lumen should be brushed, however theminimal number should be identified as “until the brush comes outclean.”

In the case of reprocessors or automatic systems used to clean anddisinfect endoscopes or any kind of tubing used for respirators orhemodialysis units, these systems rely heavily on harsh chemicals thatwash the exterior surfaces and are also forced circulated through thetubing and lumens, with the hope to remove all pathogens. If theconnections of the endoscopes or reprocessed tubing to the feedingbiocidal fluid lines of the reprocessors are done improperly or thecleaning and high-level disinfection process is interrupted or faultydue to wrong programming of the reprocessor, that can generate animproper processing, which is completely transparent (non-detected) tothe operator. Even more, the diminished processing of difficult to reachareas or intricate geometries, can allow the survival of pathogens afterthe reprocessing inside the endoscopes or any kind of tubing used forrespirators or hemodialysis units.

This is why new methodologies and technologies are needed for cleaningand high-level disinfection of endoscopes, arthroscopes, laparoscopes,bronchoscopes, nasopharygoscopes, duodenoscopes, cystoscopes,ventilators, respirators, hemodialysis units, which will be easy toapply, environmentally friendly, and non-specific to the type ofpathogen. This can be accomplished by using the focused acousticpressure shockwaves or special high-intensity pressure waves orlow-frequency ultrasound based on specific characteristics that theypossess, as follows:

-   -   a. They are applied from the exterior of the instrumentation,        which can help with the cleaning and decontamination of all        sorts of instrumentation with large dimensional variation.    -   b. Do not have detrimental effects on the cleaned surfaces or        materials, due to specific targeting of their action only on the        biological and pathogenic material.    -   c. Can get in difficult to reach areas of the instrumentation        for an efficient cleaning and decontamination of the “hiding”        pathogens.    -   d. Do not generate any heat during processing, which is        significant for keeping intact the quality of materials used in        the construction of the instrumentation, and do not create any        restrictions on their usage.    -   e. Are non-specific to a type of pathogen, as usually the        chemicals are, due to their pure mechanical/kinetic action on        the contamination material.    -   f. Do not generate pathogen mutations, since the detaching from        the instrumentation surfaces (exterior and interior) and        eventual breaching of pathogen integrity is relying only on        mechanical forces.    -   g. They are capable to clean and disinfect intricate accessories        for the reusable devices or systems, as the respirator's masks,        endoscopes or hemodialysis units or respirators' valves, etc.    -   h. Do not require energy intensive and complicated processes,        which makes them energy and time efficient.    -   i. Can be used in combination with any fluid solution that can        contain only purified water, or if needed with any type of        biocides or enzymes.    -   j. Do not require an extensive number of steps for processing,        which reduces possible mistakes by the personnel involved in the        cleaning and disinfection process.    -   k. Can combine the cleaning and disinfection in one single        phase.    -   l. Seamlessly can be integrated into existing cleaning and        disinfection systems and processing, without any major        modifications.    -   m. Can be integrated in manually or semi-automated or completely        automated cleaning and disinfection systems/processes or        equipment.    -   n. Are environmentally friendly.

In general, the focused acoustic pressure shockwaves or some specialhigh-intensity pressure waves or low-frequency ultrasound produced bythe proposed embodiments will have a compressive phase and a tensilephase during one cycle of the acoustic pressure shockwaves/pressurewaves. In the compressive phase, positive compressive pressures areproduced and in tensile phase significant negative pressures aregenerated that produce cavitation bubbles, which when reaching theirfull dimensions implode/collapse with high-speed jets in excess of 100m/s. These two synergetic effects, work in tandem to produce forces thatcan dislodge bacteria, viruses, fungi, biological material from theexternal and internal surfaces of the reprocessed systems and also candestroy individual bacterium, virus, fungus, and other micro-organismsby affecting their structural integrity.

The high mechanical tension and pressures found at the front of thefocused acoustic pressure shockwave or of the special high-intensitypressure waves distinguishes them from other kinds of sound waves, suchas ultrasonic waves. The focused acoustic pressure shockwaves or specialhigh-intensity pressure waves consist of a dominant compressive pressurepulse, which climbs steeply up to maximum one hundred Mega-Pascals (MPa;1 MPa=10 bar) within a few nanoseconds and then falls back to zerowithin a few microseconds. The final portion of the pressure profile ischaracterized by negative pressures of minus five to fifteenMega-Pascals (tensile region of the acoustic pressure shockwave/pressurewaves), with potential to generate cavitation in any kind of fluids. Thebubble diameter grows as the energy is delivered to the bubble. Thisenergy is released from the bubble during its collapse (implosion) inthe form of high-speed pressure micro jets and also produce rapidtransient high temperatures. For focused acoustic pressure shockwaves orspecial high-intensity pressure waves to be effective in the cleaningand high-level disinfection processes, they must be focused orconcentrated (semi-focused) or completely unfocused when sent towardsthe point at which their effect is needed. In the cleaning/disinfectionregion in general there are two basic effects, with the first beingcharacterized as direct generation of mechanical forces (primary effectfrom the positive, compressive high-pressure rise), and the second beingthe indirect generation of mechanical forces (high velocity pressuremicro jets) produced by cavitation (secondary effect from the negative,tensile pressure region).

A focused acoustic pressure shockwave or a special high-intensitypressure wave can travel larger distances easily (based on the amount ofenergy put in them at the point of origination), as long as the acousticimpedance of the medium remains the same. At the point where theacoustic impedance changes, energy is released and the acoustic pressureshockwave or pressure waves are reflected or transmitted withattenuation. Thus, the greater the change in acoustic impedance inbetween different substances, the greater the release of energy isgenerated. Based on this principle, when shockwaves/pressure wavescreated in a fluid reach a surface made of different material/solidmaterial, where the acoustic impedance changes, they deposit theirenergy and generate specific forces that easily dislodge any organicmaterial or pathogens from solid surfaces as the endoscope's lumens orany tubing internal or internal surfaces or from intricate surfacesfound in valves, connectors or masks, to name a few. The same forces canalso destroy the external membrane/envelope of bacteria and viruses, ordisintegrate the structural integrity of fungi or micro-organisms.

If the endoscope or reusable tubing from different medical devices orparts of these systems/devices are placed before the focal volume of theshockwaves (where the maximum pressures gradients are found andconsequently energy transmission/deposit), then the actual cleaning andhigh-level disinfection is done with unfocused waves. In the unfocussedregion, the shape of the pressure signal is more sinusoidal in shape,with the maximum positive pressures and the maximum negative pressureshaving lower values when compared to the focused shockwaves, whichtranslates in less energy carried by unfocused pressure waves in thetargeted region when compared to the focused shockwaves. This is why theunfocused pressure waves are used where lower energies are needed forcleaning and high-level disinfection of very sensitive instruments,devices, systems or their specific reusable parts.

The focused acoustic pressure shockwaves or specific high-intensitypressure waves (planar, pseudo-planar, radial, or unfocused waves) arehighly controlled to generate an energy output that will not produce anyundesired damage to the instruments that are cleaned and disinfected.This is accomplished based on reflector geometry and material, energysetting (input energy level of the focused acoustic pressure shockwavesor pressure waves), the total number of focused acoustic pressureshockwaves or pressure waves (planar, pseudo-planar, radial, orunfocused waves) used for cleaning/disinfection, and their frequency persecond. All these parameters dictate the total acoustic energy deliveredin one cleaning and high-level disinfection session. Reflector geometrydirectly controls the delivery of the shockwaves (focused or unfocused)or pressure waves into the targeted region and shapes their spatialdistribution in the cleaning and high-level disinfection area.

The energy settings (energy input into focused acoustic pressureshockwaves or special high-intensity pressure waves (planar,pseudo-planar, radial, or unfocused waves)) directly affect the pressureoutput into the cleaning and high-level disinfection region/zone andtogether with number of acoustic pressure shockwaves/pressure waves andtheir frequency per second, determine the total amount of energy used toreprocess the targeted devices/systems.

For cleaning and high-level disinfection of endoscopes, arthroscopes,laparoscopes, bronchoscopes, nasopharygoscopes, duodenoscopes,cystoscopes, ventilators, respirators, hemodialysis units, anotherapproach is to use ultrasound waves that have low frequency, to notproduce any heating effects. The ultrasound systems are placed either indirect contact or non-contact with the devices or components needingcleaning and high-level disinfection. Ultrasound has a tensile phasemade of positive pressures and a tensile phase that encompasses thenegative pressures. In comparison to the shockwaves or high intensitypressure waves, the repetition (frequency) of ultrasound phases is muchhigher. Thus, the ultrasound used in the embodiments presented in thisinvention have a frequency in between 10 to 900 kHz, and more preferable30 to 300 kHz, which is much higher compared to 1 to 12 Hz (preferable 2to 10 Hz) used for shockwaves/pressure waves. Also, for ultrasound thesequence of phases is continuous from positive pressure to negativepressures and then again to positive pressures in a sinusoidalcontinuous variation. This has an influence on the cavitation. Due tocyclical acoustic wave of the ultrasound, the cavitation bubbles growthis cyclical too and in general they do not reach the same size as theshockwave cavitation bubbles, which translates in less energy generatedduring their collapse. In order to reach the proper size necessary tocollapse by themselves, for the ultrasound cavitation bubbles it takesmany ultrasound cycles. Also, due to continuous oscillation indimensions, the ultrasound cavitation bubbles grow slowly in dimensionand accumulate heat, which produce a collapse as a hot spot. Thecombination of the micro jets and hot spots created by the collapsingultrasound cavitation bubbles can contribute both to the dislodging ofthe contamination material from instruments surfaces and also to thepathogen killing. In the end, the ultrasound vibrations and thecavitation bubbles generated by it have benefic effects on cleaning andhigh-level disinfection of endoscopes, arthroscopes, laparoscopes,bronchoscopes, nasopharygoscopes, duodenoscopes, cystoscopes,ventilators, respirators, hemodialysis units, and other medical devicesor components that requires reuse.

Thus, focused acoustic pressure shockwaves or special high-intensitypressure waves (planar, pseudo-planar, radial, or unfocused waves) orlow-frequency ultrasound are destroying the integrity of the bacteria byaffecting their membrane integrity. That is done via interference withbacterium mechano-transduction (transport of fluids across bacteriummembrane) due to significant localized pressure variations produced whenthe pressure pulses are generated in the region where the pathogenexists, which create sudden variation in pressure from high positivepressures to significant negative pressures. In the simplest terms, themembrane pores of the bacterium remain opened due to sudden pressurechanges and the bacteria swells until the integrity of the membrane iscompromised. According to the published scientific literature, thebacterial membrane mechano-transduction occurs at pressures of 3 MPa orless, which is well in the realm of pressure generated by focusedacoustic pressure shockwaves or special high-intensity pressure waves(planar, pseudo-planar, radial, or unfocused waves) or low-frequencyultrasound.

For viruses their shell integrity can be compromised due to thepenetrating forces generated by the micro jets produced by the collapseof cavitational bubbles formed in the tensile phase by the negativepressures. Another factor that can act on viruses are the transient hightemperatures produced during cavitational bubbles collapse, which candenature the virus and its DNA material.

Due to pure mechanical process, produced by focused acoustic pressureshockwaves and special pressure waves (planar, pseudo-planar, radial, orunfocused waves) or low-frequency ultrasound, which is involved in thedestruction of individual bacteria or viruses, there is no biochemicalprocess involved that can produce mutations. Thus, there is no developedresistance of bacteria or viruses to focused acoustic pressureshockwaves or special pressure waves (planar, pseudo-planar, radial, orunfocused waves) or low-frequency ultrasound, due to their mutation,natural selection, transformation, transduction or conjugation.

The focused acoustic pressure shockwaves and special pressure waves(planar, pseudo-planar, radial, or unfocused waves) or low-frequencyultrasound produce a kinetic effect on the exterior or interior of theendoscopes or tubing from respirators or hemodialysis units, due to theforces generated by the compressive positive pressures of theircompressive phase and due to the forces associated with micro-jetsproduced during cavitation bubbles collapse from their tensile phase.That can have a benefic influence in dislodging different pathogens asviruses, bacteria, micro-organisms, biological material, and any type ofbiofilms from the reprocessed items. Furthermore, the same effects canbe used to destroy the structural integrity of pathogens, which candisable them and eliminate their infectious capability.

In some embodiments of this invention, the dislodged individualpathogens or fragments of biofilms from the exterior or interiorsurfaces of the reprocessed devices/systems or subassemblies or parts oraccessories can be flushed away via fluid circulation (purified water ormixture of purified water and biocides) after application of shockwavesor pressure waves or low-frequency ultrasound. This allows an evenbetter chance to thoroughly clean and disinfected the reprocesseddevices/systems or subassemblies or parts or accessories.

In other embodiments, the flushing process of the reprocesseddevices/systems or subassemblies or parts or accessories can be alsodone concomitantly during the actual cleaning and high-leveldisinfection that employs focused acoustic pressure shockwaves andspecial pressure waves (planar, pseudo-planar, radial, or unfocusedwaves) or low-frequency ultrasound. However, even in these situations,the amount of biocide used is reduced when compared to existingtechniques, which significantly contributes to less environmental impactduring the discarding of such processing fluids and also reduces theamount of rinsing needed in the subsequent step of cleaning andhigh-level disinfection.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic representation of ventilator system structure andfunctionality known in the prior art.

FIG. 2 is a schematic representation of ventilators' reusable tubingsystem known in the prior art.

FIG. 3 is a schematic representation of endoscope structure andfunctionality known in the prior art.

FIG. 4 is a schematic representation of features characteristic forfocused pressure shockwaves known in the prior art.

FIG. 5 is a schematic representation of features characteristic forplanar pressure waves known in the prior art.

FIG. 6 is a schematic representation of features characteristic forradial pressure waves known in the prior art.

FIG. 7 is a schematic representation of typical ellipsoidal geometrythat is used for focusing shockwaves known in the prior art.

FIG. 8 is schematic representation of typical semi-ellipsoidal reflectorused for focused shockwave applicators known in the prior art.

FIG. 9 is a schematic representation of an electrohydraulic focusedshockwaves system for cleaning and high-level disinfection of endoscopesor reusable tubing from ventilators and dialysis machines and othermedical devices in one embodiment of the present invention.

FIG. 10 is a schematic representation of an electrohydraulic radialpressure waves system for cleaning and high-level disinfection ofendoscopes or reusable tubing from ventilators and dialysis machines andother medical devices in one embodiment of the present invention.

FIG. 11 is a schematic representation of an electrohydraulicpseudo-planar pressure waves system for cleaning and high-leveldisinfection of endoscopes or reusable tubing from ventilators anddialysis machines and other medical devices in one embodiment of thepresent invention.

FIG. 12 is a schematic representation of a laser electrohydraulicfocused shockwaves system for cleaning and high-level disinfection ofendoscopes or reusable tubing from ventilators and dialysis machines andother medical devices in one embodiment of the present invention.

FIG. 13 is a schematic representation of a cylindrical coil-producedelectromagnetic focused shockwaves system for cleaning and high-leveldisinfection of endoscopes or reusable tubing from ventilators anddialysis machines and other medical devices in one embodiment of thepresent invention.

FIG. 14 is a schematic representation of a flat coil-producedelectromagnetic focused shockwaves system for cleaning and high-leveldisinfection of endoscopes or reusable tubing from ventilators anddialysis machines and other medical devices in one embodiment of thepresent invention.

FIG. 15 is a schematic representation of a piezo crystals/piezoceramics-produced piezoelectric focused shockwaves system for cleaningand high-level disinfection of endoscopes or reusable tubing fromventilators and dialysis machines and other medical devices in oneembodiment of the present invention.

FIG. 16 is a schematic representation of a piezo fibers-producedpiezoelectric focused shockwaves system for cleaning and high-leveldisinfection of endoscopes or reusable tubing from ventilators anddialysis machines and other medical devices in one embodiment of thepresent invention.

FIG. 17A is a schematic representation of a manual or semi-automaticsystem for cleaning and high-level disinfection of endoscopes orreusable tubing from ventilators and dialysis machines and other medicaldevices using one focused shockwave applicator in direct contact withendoscope or tubing, according to one embodiment of the presentinvention.

FIG. 17B is a cross-sectional schematic representation of the systemillustrated in FIG. 17A taken along line A-A, according to oneembodiment of the present invention.

FIG. 18 illustrates a manual or semi-automatic fixture for cleaning andhigh-level disinfection of endoscopes or reusable tubing fromventilators and dialysis machines and other medical devices using oneapplicator in direct contact with endoscope or tubing, according to oneembodiment of the present invention.

FIG. 19A is a schematic representation of a manual or semi-automaticsystem for cleaning and high-level disinfection of endoscopes orreusable tubing from ventilators and dialysis machines and other medicaldevices using two confocal and opposite focused shockwave applicators indirect contact with the endoscope or tubing, according to one embodimentof the present invention.

FIG. 19B is a cross-sectional view of the system illustrated in FIG. 19Ataken along line A-A, according to one embodiment of the presentinvention.

FIG. 20A is a schematic representation of a manual or semi-automaticsystem for cleaning and high-level disinfection of endoscopes usingthree focused shockwave applicators in direct contact with theendoscope, according to one embodiment of the present invention.

FIG. 20B is a cross-sectional view of FIG. 20A for a manual orsemi-automatic system for cleaning and high-level disinfection ofendoscopes using three focused shockwave applicators in direct contactwith endoscope, according to one embodiment of the present invention.

FIG. 21A is a schematic representation of a manual or semi-automaticsystem for cleaning and high-level disinfection of reusable tubing fromventilators and dialysis machines and other medical devices using threefocused shockwave applicators in direct contact with the tubing,according to one embodiment of the present invention.

FIG. 21B is cross-sectional view of FIG. 21A for a manual orsemi-automatic system for cleaning and high-level disinfection ofreusable tubing from ventilators and dialysis machines and other medicaldevices using three focused shockwave applicators in direct contact withthe tubing, according to one embodiment of the present invention.

FIG. 22 is a schematic representation of a manual or semi-automaticsystem for cleaning and high-level disinfection of reusable tubing fromventilators and dialysis machines and other medical devices using threefocused shockwave applicators with no direct contact with the tubing,according to one embodiment of the present invention.

FIG. 23 is a schematic representation of a cleaning and high-leveldisinfection system for endoscopes or reusable tubing from ventilatorsand dialysis machines and other medical devices using multiple focusedshockwave applicators in direct contact with the endoscope or tubing,according to one embodiment of the present invention.

FIG. 24 is a schematic representation of a cleaning and high-leveldisinfection system for endoscopes or reusable tubing from ventilatorsand dialysis machines and other medical devices using focused shockwavesapplicators having multiple confocal reflectors, according to oneembodiment of the present invention.

FIG. 25A is a schematic representation of a cleaning and high-leveldisinfection system for endoscopes or reusable tubing from ventilatorsand dialysis machines and other medical devices using shockwaveelongated applicators having elongated reflectors with multiple sparkgaps, according to one embodiment of the present invention.

FIG. 25B is cross-sectional view of FIG. 25A showing the cleaning andhigh-level disinfection system for endoscopes or reusable tubing fromventilators and dialysis machines and other medical devices usingshockwave elongated applicators having elongated reflectors withmultiple spark gaps, according to one embodiment of the presentinvention.

FIG. 26 is a schematic representation of a cleaning and high-leveldisinfection system for endoscopes or reusable tubing from ventilatorsand dialysis machines and other medical devices using shockwaveapplicators or pressure wave applicators having pipe reflectors withmultiple spark gaps, according to one embodiment of the presentinvention.

FIG. 27 is a schematic cross-sectional view of a fixture for manual orsemi-automatic cleaning and high-level disinfection of endoscopes orreusable tubing from ventilators and dialysis machines and other medicaldevices using focused shockwave applicators or pressure waveapplicators, according to one embodiment of the present invention.

FIGS. 28A-C are 3D schematic representations of the fixture shown inFIG. 27 for manual or semi-automatic cleaning and high-leveldisinfection of endoscopes or reusable tubing from ventilators anddialysis machines and other medical devices using focused shockwaveapplicators or pressure wave applicators, according to one embodiment ofthe present invention.

FIGS. 29A and 29B are schematic 3D blow-out representations of thefixture from FIGS. 27 and 28A-28C for manual or semi-automatic cleaningand high-level disinfection of endoscopes or reusable tubing fromventilators and dialysis machines or and medical devices using focusedshockwave applicators and pressure wave applicators, according to oneembodiment of the present invention.

FIG. 30 is a schematic representation of a full ellipsoidal reflectorand shockwave focusing relationship known in the prior art.

FIG. 31 is a schematic representation of the geometry of afull-ellipsoidal reflector with a channel/opening to move the endoscopeor reusable tubing from ventilators and dialysis machines and othermedical devices through the focal volume of focused shockwaves duringcleaning and high-level disinfection, according to one embodiment of thepresent invention.

FIG. 32A is a schematic representation of a system using focusedshockwaves applicators having full-ellipsoidal reflectors with achannel/opening to move the endoscope or reusable tubing fromventilators and dialysis machines and other medical devices through thefocal volume during cleaning and high-level disinfection, according toone embodiment of the present invention.

FIG. 32B is cross-section view along line A-A of FIG. 32A, according toone embodiment of the present invention.

FIGS. 33A-33C are schematic 3D representations of the system illustratedin FIGS. 32A and 32B using focused shockwaves applicators havingfull-ellipsoidal reflectors with a channel/opening to move the endoscopeor reusable tubing from ventilators and dialysis machines and othermedical devices through the focal volume during cleaning and high-leveldisinfection, according to one embodiment of the present invention.

FIGS. 34A-34C are schematic representations of a system using focusedshockwaves applicators having full-ellipsoidal reflectors with a lateralslot to move the endoscope or reusable tubing from ventilators anddialysis machines and other medical devices through the focal volumeduring cleaning and high-level disinfection, according to one embodimentof the present invention.

FIGS. 35A-35C are schematic representations of a system using focusedshockwaves applicators having full-ellipsoidal reflectors with a topslot to move the endoscope or reusable tubing from ventilators anddialysis machines or from any other medical devices through the focalvolume during cleaning and high-level disinfection, according to oneembodiment of the present invention.

FIG. 36 is a schematic representation of a system with an array ofapplicators having full-ellipsoidal reflectors with a lateral slot tomove the endoscope or reusable tubing from ventilators and dialysismachines or from any other medical devices through the focal volumeduring cleaning and high-level disinfection, according to one embodimentof the present invention.

FIG. 37 is a schematic representation of a piezoelectric systemproducing planar waves for cleaning and high-level disinfection ofendoscopes or reusable tubing from ventilators and dialysis machines orfrom any other medical devices, according to one embodiment of thepresent invention.

FIG. 38A is a schematic representation of features characteristic forultrasound pressure waves known in the prior art.

FIG. 38B is a schematic representation of an ultrasonic system producingmultiple low frequency ultrasound waves for cleaning and high-leveldisinfection of endoscopes or reusable tubing from ventilators anddialysis machines and other medical devices, according to one embodimentof the present invention.

FIG. 39 is a schematic representation of a multiple electrohydraulicradial pressure waves system used for cleaning and high-leveldisinfection simultaneously of two endoscopes or two reusable tubes fromventilators and dialysis machines and other medical devices, accordingto one embodiment of the present invention.

FIG. 40 is a schematic representation of a multiple laser-producedelectrohydraulic radial pressure waves system used for cleaning andhigh-level disinfection simultaneously of two endoscopes or two reusabletubes from ventilators and dialysis machines and other medical devices,according to one embodiment of the present invention.

FIG. 41 is a schematic representation of a system with an array ofplatform applicators producing radial or pseudo-planar pressure wavesfor cleaning and high-level disinfection of endoscopes or tubing fromventilators and dialysis machines and other medical devices, accordingto one embodiment of the present invention.

FIGS. 42A and 42B are schematic representations of a system with anarray of four double-applicators rotated with 90 degrees for eachsubsequent applicator that are producing radial or pseudo-planarpressure waves for cleaning and high-level disinfection of endoscopes ortubing from ventilators and dialysis machines and other medical devices,according to one embodiment of the present invention.

FIG. 43 is a schematic representation of a system with an array of fourdouble-applicators rotating with 90 degrees back and forth that areproducing radial or pseudo-planar pressure waves for cleaning andhigh-level disinfection of endoscopes or tubing from ventilators anddialysis machines and other medical devices, according to one embodimentof the present invention.

FIG. 44A is a schematic representation of an automatic shockwaves orpseudo-planar waves or radial waves reprocessor with one reflector forcleaning and high-level disinfection of endoscopes or tubing fromventilators and dialysis machines and other medical devices, accordingto one embodiment of the present invention.

FIG. 44B is a cross-sectional view along line A-A of FIG. 44A, accordingto one embodiment of the present invention.

FIG. 44C is a cross-sectional view along line B-B of FIG. 44A, accordingto one embodiment of the present invention.

FIGS. 45A and 45B are schematic 3D representations of an automaticshockwaves or pseudo-planar waves or radial waves reprocessor, as showin FIGS. 44A-44C, with one reflector for cleaning and high-leveldisinfection of endoscopes or tubing from ventilators and dialysismachines and other medical devices, according to one embodiment of thepresent invention.

FIGS. 46A and 46B are schematic representations of an automaticshockwave or pseudo-planar waves or radial waves reprocessor with twoopposite reflectors for cleaning and high-level disinfection ofendoscopes or tubing from ventilators and dialysis machines and othermedical devices, according to one embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the invention will be described with reference to theaccompanying figures, wherein like numbers represent like elementsthroughout. Further, it is to be understood that the phraseology andterminology used herein is for the purpose of description and should notbe regarded as limiting. The use of “including”, “comprising”, or“having” and variations thereof herein is meant to encompass the itemslisted thereafter and equivalents thereof, as well as additional items.The terms “connected”, and “coupled” are used broadly and encompass bothdirect and indirect mounting, connecting, and coupling. Further,“connected” and “coupled” are not restricted to physical or mechanicalconnections or couplings.

It is a further objective of the present inventions to provide a meansof controlling the energy via the amount of energy generated by thefocused acoustic pressure shockwave, or special pressure waves (planar,pseudo-planar, radial, or unfocused waves), or low-frequency ultrasoundgenerators (using the energy settings), total number of the shockwavesor pressure waves, repetition frequency for the shockwaves or pressurewaves or ultrasound, duration of the cleaning and high-leveldisinfection process, and through the special construction of thereflectors used in some of the applicators presented in the presentinventions.

It is a further objective of the present inventions to provide focusedshockwaves or special high-intensity pressure waves (planar,pseudo-planar, radial, or unfocused waves) or low-frequency ultrasoundgenerating devices that are modular, do not need high maintenance andcan, if needed, be applied/used in conjunction and synergy with otherdevices and cleaning and high-level disinfection systems.

The inventions summarized below and defined by the enumerated claims arebetter understood by referring to the following detailed description,which is preferably read in conjunction with the accompanyingdrawing/figure. The detailed description of a particular embodiment, isset out to enable one to practice the invention, it is not intended tolimit the enumerated claims, but to serve as a particular examplethereof.

The inventions described herein are not intended to be limited tospecific embodiments that are provided by way of example, but extend tothe full scope of such claims of a corresponding issued patent.

Also, the list of embodiments presented in this patent is not anexhaustive one and for those skilled in the art, new applications andoptimization methods can be found within the scope of the invention.

As presented in FIGS. 1 and 2 , a ventilator system 10 is a machine thathelps a patient 11 breathe by blowing oxygen into the lungs and removingcarbon dioxide out of the lungs. The ventilator console 12 is attachedto a ventilator intubating breathing tubing 13 at one end that is placedin the patient's 11 mouth or in an opening through the neck into thewindpipe (trachea), which is called a tracheostomy. The ventilatorexternal tubing 13A is made of the inspiratory and expiratory breathingtubing. The breath in air direction 13B is the inspiratory direction andthe breath out air direction 13C is the expiratory direction. Theselection of airflow direction is done with a series of one-way valves17. The adjustable pressure-limiting valve 15 (commonly abbreviated toAPL valve, and also referred to as an expiratory valve, relief valve orspill valve) is a type of flow control valve used in anesthesia systemsor ventilators, as part of a breathing system. It allows excess freshgas flow and exhaled gases to leave the system while preventing ambientair from entering. The air or oxygen bag/reservoir 14 provides via theswitch 16 the gas or gases mixture necessary for the inspiration phaseof the patient 11. The expiration gas mixture contains carbon dioxide(CO₂) and to purify the air from that, a CO₂ absorber 18 is used on thebreath out air direction 13C. Sometimes it is necessary to introduceanesthetic gas or medication via the anesthetic gas or medicationvaporizer 19. As seen in FIG. 2 , for patient feeding during the use ofthe ventilator system 10, the nasogastric tube 21 is introduced throughthe esophagus by the medical personnel 20, who also supervises thecorrect functioning and possible adjustments of the ventilator system10. For easily connect and disconnect different parts of the ventilatorintubating breathing tubing 13 and/or the ventilator external tubing13A, the connectors 23 and the connector snapping parts 22 are used. TheY-connector piece 24 is used to separate or converge the inspiratory andexpiratory breathing tubing.

In general, the ventilators' breathing circuits, including theventilator intubating breathing tubing 13 and the ventilator externaltubing 13A, should be changed every 7 days for a patient that uses theventilator system 10 for long period of time. Between uses on differentpatients, the reusable contaminated components of the breathing systemor patient circuit (e.g., tracheal tube/ventilator intubating breathingtubing 13 or face mask) inspiratory and expiratory ventilator externaltubing 13A, Y-connector piece 24 (see FIG. 2 ), air or oxygenbag/reservoir 14, one-way valves 17, and humidifier 25 (see FIG. 2 ),must be subject to high-level disinfection. The ventilator's humidifier25, the ventilator intubating breathing tubing 13 and ventilatorexternal tubing 13A are connected to the patient's mouth and nose with aclosed cycle. The exudates and bacteria or viruses from inside the bodyduring exhalation can contaminate the ventilator's pipeline. Thehumidified and heated air in the ventilator external tubing 13A can forma moist, warm, and airtight environment, and can form condensed waterunder the interaction with the cold air outside the ventilator externaltubing 13A, providing an environment for the pathogens to multiply andform aerosols with inhaled gases, enter the respiratory tract, and causerepeated lung infections.

Interesting to note that inadequate and prolonged use of ventilators cancause the ventilator-associated pneumonia (VAP), which is generated bymicrobial contamination in the lungs. Microbes may enter the lung duringintubation or mechanical ventilation. Common species are Pseudomonas,Staphylococcus aureus, Enterobacteriaceae, Streptococcus, Haemophilus,Acinetobacter, and Neisseria. These pathogens generally remain in thelung, spreading into blood or pleural space in less than ten percent ofcases. The source of causative pathogens are the bronchoscopes, tubing,endotracheal cuffs, and other respiratory accessories and instruments.Pathogens can also originate from the environment (air, water, fomites)or be transmitted between staff and patients. These emphasize even morethe necessity to use cleaning and high-level decontamination for certaincomponents of the ventilators, especially in the cases where highlycontagious pathogens are involved.

Chemical and physical methods of disinfection are used to cleanventilator's different parts, as inspiratory and expiratory ventilatorexternal tubing 13A, Y-connector piece 24 (see FIG. 2 ), air or oxygenbag/reservoir 14, one-way valves 17, and humidifier 25. Usually, theentire ventilator external tubing 13A is removable, including theadjustable pressure-limiting valve 15, which may also have a flowmeasurement device or a water trap, or both. The physical methods forhigh-level disinfection include hot-water disinfection (pasteurization)or steam (e.g., autoclaving at lower temperature). Pasteurization is anon-toxic, cost-effective alternative to high-level disinfection withchemical germicides. Equipment should be submerged for at least 30minutes in water at a temperature of about 70° C. (less than thetemperature that typically damages plastic). Pasteurization can beaccomplished using a commercial washer or pasteurizer. Steamsterilization is an inexpensive and effective method for sterilizationor high-level disinfection, but it can be unsuitable for processingplastics with low melting points, powders or anhydrous oils. Afterpasteurization, wet equipment is typically dried in a hot-air dryingcabinet and then dry-stored in closed packages. The use of mechanical orchemical cleaning and high-level disinfection for ventilator tubes canimprove the qualification rate of disinfection and reduce the number ofpathogen colonies in the tube. Unfortunately, bacterial and/or viralspores may survive after these methods. Microbiological sampling can beused to verify that high-level disinfection has resulted in thedestruction of vegetative bacteria or viral particles. However, suchsampling is not routinely recommended. The decontamination andhigh-level disinfection of ventilators is a process that takes 2 hours,which is time-consuming and results in a lot of wear and tear and timeout of service.

Physicians also use medical tubing 30 (such as endoscopes and othermedical device tubes), as presented in FIG. 3 , to diagnose and treatnumerous medical disorders. The flexible endoscope is constructed ofseveral systems that operate simultaneously to produce a highlytechnical, yet effective diagnostic and therapeutic medical device. Thebasic design of most flexible endoscopes consists of a light guideconnector (not specifically shown in FIG. 3 ), umbilical or universalcord 32, control body or endoscope handle 31, and insertion tube 33 withinternal channels (suction channel 34, air channel 35, water channel 36,and water-jet channel 37). At the distal end of the insertion tube 33 isthe nozzle 33A that is inside the patient. The suction channel 34 has atits proximal end a suction connector 34A and on the endoscope handle 31a suction valve 34B. At the proximal end of the endoscopes 30, the airchannel 35 has an air pipe connector 35A, the water channel 36 has awater bottle connector 36A, and the water-jet channel 37 has a water-jetconnector 37A. On the endoscope handle 31 a biopsy valve 38 and anair/water valve 39 are present. The endoscope different systems includethe air and water system, the suction and operating channel system, themechanical system, the endoscopic retrograde cholangiopancreatography(ERCP) elevator system, the optical system, and the electrical system.

Even though endoscopes represent a valuable diagnostic and therapeutictool in modern medicine and the incidence of infection associated withtheir use reportedly is low, lately more healthcare-associated outbreakshave been linked to contaminated endoscopes than to any other medicaldevice. Infections suspected to have occurred after lapses inreprocessing of duodenoscopes were related to failure to use appropriateattachments to specialty channels or failure to clean all channelsduring reprocessing. Patient-to-patient transmission ofcarbapenem-resistant Enterobacteriaceae or other multidrug-resistantorganisms by contaminated duodenoscopes, despite appropriate and optimalreprocessing, has been reported all of the world and resulted inpatients' deaths. Some of these devices cannot be steam sterilizedbecause they are heat-sensitive. Additionally, sterilization usingethylene oxide (EtO) can be too time-consuming for routine use inbetween patients. Other new technologies, such as hydrogen peroxide gasplasma and peracetic acid reprocessors, provide faster cycle times.However, evidence that sterilization of these items improves patientcare by reducing the infection risk is lacking. Many newer models ofthese instruments can withstand steam sterilization, which for criticalitems is the preferred method.

Flexible endoscopes, because of the types of body cavities they enter,may acquire high levels of microbial contamination (bioburden) duringeach use. To prevent the spread of health-care-associated infections,all heat-sensitive endoscopes (e.g., gastrointestinal endoscopes,bronchoscopes, nasopharygoscopes) must be properly cleaned and, at aminimum, subjected to high-level disinfection after each use. High-leveldisinfection can be expected to destroy all microorganisms, althoughwhen high numbers of bacterial spores are present, a few spores mightsurvive.

In general, during the manual reprocessing of the endoscopes (see FIG. 3), it is needed to meticulously clean the entire endoscope, includingvalves (suction valve 34B, biopsy valve 38, and air/water valve 39),channels (suction channel 34, air channel 35, water channel 36, andwater-j et channel 37), connectors (suction connector 34A, air pipeconnector 35A, water bottle connector 36A, and water-jet connector 37A)and all detachable parts using only specific cleaning and disinfectiondevices (such as brushes) designed for the endoscope model beingcleaned. The flushing and brushing of all accessible channels aremandatory to remove all organic (e.g., blood or tissue) and otherresidues. To facilitate access to all surfaces, the valves (suctionvalve 34B, biopsy valve 38, and air/water valve 39) during cleaning mustbe repeatedly actuated. The cleaning of the external surfaces andcomponents of the endoscope is done using a soft cloth, a sponge, orbrushes. If enzymatic detergents are used, they need to be discardedafter each use, since these products are not microbicidal and will notretard microbial growth. During high-level disinfection the channels ofthe endoscopes (suction channel 34, air channel 35, water channel 36,and water-j et channel 37), the access connectors (suction connector34A, air pipe connector 35A, water bottle connector 36A, and water-jetconnector 37A), and valves (suction valve 34B, biopsy valve 38, andair/water valve 39) are repeatedly flushed and cleaned with specializedbiocides that are recommended by Food and Drug Administration (FDA),Centers for Disease Control and Prevention (CDC), or differentmanufacturers.

Automated endoscope reprocessors offer several advantages over manualreprocessing. They automate and standardize several importantreprocessing steps, reduce the likelihood that an essential reprocessingstep will be skipped, and reduce personnel exposure to high-leveldisinfectants or chemical sterilants. Establishment of correctconnectors between the reprocessor and the endoscope is critical toensure complete flow of disinfectants and rinse water. Also, selectionof the proper cleaning and high-level disinfection cycle based on thetype of endoscope is crucial for a proper reprocessing.

Due to the types of body's cavities that are serviced by flexibleendoscopes 30, they acquire high levels of microbial contamination(bioburden) during each use. The same is happening with reusablecontaminated medical tubing 30 (see FIG. 9 ) from ventilators or fromdialysis machines that can get contaminated from breathing and fromblood, respectively. Endoscopes 30 are frequently contaminated withblood, particularly when a biopsy is taken. Flexible endoscopes 30 arealso exposed to other soils, which vary based upon the part of the bodywhere the scope is use (i.e., fecal matter in a colonoscope).

Research has shown that bioburden left on instruments interferes withthe sterilization process and can render it ineffective. Making sure anendoscope 30 is as clean as possible is thus paramount to preventingcross contamination of any patient undergoing a procedure. Ensuringcleanliness of endoscopes 30 should be part of any hospital's infectioncontrol program. Cleaning should be monitored since it is directlycorrelated to reducing hospital-acquired infections. Failure tocompletely dissemble, clean, and high-level disinfect endoscopes partshas led to infections in patients.

As with antibiotics, reduced susceptibility (or acquired “resistance”)of bacteria to disinfectants can arise by either chromosomal genemutation or acquisition of genetic material in the form of plasmids ortransposons. When changes occur in bacterial susceptibility that rendersan antibiotic ineffective against an infection previously treatable bythat antibiotic, the bacteria are referred to as “resistant.” Therotational use of disinfectants in some environments (e.g., pharmacyproduction units) has been recommended and practiced in an attempt toprevent development of resistant microbes.

Contaminated disinfectants and antiseptics have been occasional vehiclesof health-care infections and pseudo-epidemics for more than 50 years.Published reports describing contaminated disinfectants and antisepticsolutions leading to health-care-associated infections have shown thatmembers of the genus Pseudomonas (e.g., P. aeruginosa) are the mostfrequent isolates from contaminated disinfectants—recovered from 80% ofcontaminated products. Their ability to remain viable or grow inuse-dilutions of disinfectants is unparalleled. This survival advantagefor Pseudomonas results presumably from their nutritional versatility,their unique outer membrane that constitutes an effective barrier to thepassage of germicides, and/or efflux systems. Although the concentratedsolutions of the disinfectants have not been demonstrated to becontaminated at the point of manufacture, an undiluted phenolic can becontaminated by Pseudomonas spores during use. In the illness associatedwith contaminated disinfectants, the product was used to disinfectpatient-care equipment, such as endoscopes, cystoscopes, or reusablecontaminated tubing from ventilators and dialysis systems, to name afew. Germicides used as disinfectants that were reported to have beencontaminated include chlorhexidine, quaternary ammonium compounds,phenolics, and pine oil.

Outbreaks involving removable endoscope parts such as suction valves andendoscopic accessories designed to be inserted through flexibleendoscopes such as biopsy forceps emphasize the importance of cleaningto remove all foreign matter before high-level disinfection orsterilization.

To summarize, endoscope disinfection or sterilization with a liquidchemical sterilant involves five steps after leak testing:

-   -   1) Clean—mechanically clean internal and external surfaces,        including brushing internal channels (suction channel 34, air        channel 35, water channel 36, and water-jet channel 37) and        flushing each internal channel with water and a detergent or        enzymatic cleaner (leak testing is recommended for endoscopes        before immersion).    -   2) Disinfect—immerse endoscope 30 in high-level disinfectant (or        chemical sterilant) and perfuse (eliminates air pockets and        ensures contact of the germicide with the internal channels)        disinfectant into all accessible channels (suction channel 34,        air channel 35, water channel 36, and water-jet channel 37), and        expose for a time recommended for specific products.    -   3) Rinse—rinse the endoscope 30 and all channels (suction        channel 34, air channel 35, water channel 36, and water-jet        channel 37) with sterile water, filtered water (commonly used        with automated endoscope reprocessors) or tap water (i.e.,        high-quality potable water that meets federal clean water        standards at the point of use).    -   4) Dry—rinse the insertion tube 33 and inner channels (suction        channel 34, air channel 35, water channel 36, and water-jet        channel 37) with alcohol, and dry with forced air after        disinfection and before storage.    -   5) Store—store the endoscope 30 in a way that prevents        recontamination and promotes drying (e.g., hung vertically).

For cleaning and high-level disinfection of endoscopes, arthroscopes,laparoscopes, bronchoscopes, nasopharygoscopes, duodenoscopes,cystoscopes, ventilators, respirators, hemodialysis units, as analternative effective method or in combination with other methods, isthe use of extracorporeal focused acoustic pressure shockwaves andspecial pressure waves (planar, pseudo-planar, radial, or unfocusedwaves) or low-frequency ultrasound. A significant advantage of usingshockwaves or pressure waves or low-frequency ultrasound, when comparedwith existing disinfectants/biocides, is that their effect is based onlyon mechanical action produced by the compressive and tensile phases thatare generated during the time the shockwaves or pressure waves orultrasound waves pass through the area/zone of interest.

Thus, the focused acoustic pressure shockwaves or pressure waves or lowfrequency ultrasound produced by the proposed embodiments will have acompressive phase (produces compressive pressures) and a tensile phase(negative pressures that produce cavitation bubbles, which collapse withhigh-speed jets) during one cycle of the focused acoustic pressureshockwaves or pressure waves or ultrasound waves. These two synergeticeffects, work in tandem, by acting at macro (compressive phase) andmicro level (cavitation jets of the tensile phase), which is enhancingthe effects of the focused acoustic pressure shockwaves or pressurewaves or low frequency ultrasound waves on biofilms or soiling ordirectly on different pathogens present in reusable contaminatedequipment and their sub-assemblies or parts.

In lithotripsy, kidney stone fragmentation using focused shockwaves,cavitation is believed to be the primary cause of stone disintegration.Based on the same principle the biofilms can be obliterated anddislodged from external or internal surfaces of different medicaldevices or systems, as confirmed by experimental results. In general,the focused acoustic pressure shockwaves or pressure waves (planar,pseudo-planar, radial, or unfocused waves) or low-frequency ultrasoundare highly controlled to generate an energy amount fitted for thepurpose of a specific application. This is accomplished based onreflector geometry and its material (for shockwaves and pressure waves),energy setting (input energy level of the focused acoustic pressureshockwaves or pressure waves or ultrasound), number of focused acousticpressure shockwaves or pressure waves (planar, pseudo-planar, radial, orunfocused waves) or the treatment duration for low-frequency ultrasound,and finally by their frequency per second that dictates the totalacoustic energy delivered during the cleaning and high-leveldisinfection of endoscopes, arthroscopes, laparoscopes, bronchoscopes,nasopharygoscopes, duodenoscopes, cystoscopes, ventilators, respirators,hemodialysis units, or any reusable contaminated medical systems ortheir parts. Reflector geometry directly controls the delivery of theshockwaves (focused or unfocused) or pressure waves into the targetedregion and shapes their spatial distribution in the same targetedregion. The energy setting is the energy input to generate focusedacoustic pressure shockwave 40 or pressure waves (acoustic planarpressure wave 374 or pseudo-planar pressure wave 40 or acoustic radialpressure wave 40) and low-frequency ultrasound waves 380 and 381, asdescribed in FIGS. 4, 5, 6, 37, 38A and 38B. The energy setting isdirectly affecting the pressure output into the targeted region/zone andtogether with the number of shockwaves/pressure waves and theirfrequency per second, or the frequency setting and treatment durationfor ultrasound, determine the total amount of energy deposited insidethe targeted region.

The peak positive compressive pressures of the focused acoustic pressureshockwave 40 or pressure waves (acoustic planar pressure wave 374 orpseudo-planar pressure wave 40 or acoustic radial pressure wave 40) andlow-frequency ultrasound waves 380 and 381 are concentrated to aspecifically localized region, as can be seen from FIGS. 4, 5, 6, 37,38A and 38B, causing a disruption, movement or stretching of differentorganic or non-organic materials in the targeted region at amplitudesdepending on the structure of each material/substance. This mechanicalvibration combined with the microjets produced by the collapse of thecavitational bubbles, can produce in a liquid acoustic streaming andmicro-streaming that can contribute to the dislodging and integritydestruction of individual bacteria, viruses, micro-organisms ororganized structures as biofilms from the tubing walls of theendoscopes, arthroscopes, laparoscopes, bronchoscopes,nasopharygoscopes, duodenoscopes, cystoscopes, ventilators, respirators,or hemodialysis units. Furthermore, localized/transient thermal effectscreated during collapse of the cavitation bubbles can also kill bacteriaand viruses.

The focused acoustic pressure shockwave 40 or pressure waves (acousticplanar pressure wave 374 or pseudo-planar pressure wave 40 or acousticradial pressure wave 40) and low-frequency ultrasound waves 380 and 381can also generate free radicals in a fluid that have a potentialdestructive effect on bacteria, viruses or biofilms. Thus, focusedacoustic pressure shockwave 40 or pressure waves (acoustic planarpressure wave 374 or pseudo-planar pressure wave 40 or acoustic radialpressure wave 40) and low-frequency ultrasound waves 380 and 381 candestroy bacteria, viruses, and various other micro-organisms, byaffecting their membrane integrity. For viruses their external shellintegrity can be compromised due to the penetrating forces generated bythe micro-jets produced by the collapse of cavitational bubbles formedin the tensile phase by the negative pressures. This effect is alsocombined with the transient high temperatures produced duringcavitational bubbles collapse, which can denature the virus and its DNAmaterial. Most important, in these mechanisms of action of the focusedacoustic pressure shockwave 40 or pressure waves (acoustic planarpressure wave 374 or pseudo-planar pressure wave 40 or acoustic radialpressure wave 40) and low-frequency ultrasound waves 380 and 381, thereis no biochemical process involved that can produce mutations. Thus,there is no developed resistance of bacteria or viruses to the focusedacoustic pressure shockwave 40 or pressure waves (acoustic planarpressure wave 374 or pseudo-planar pressure wave 40 or acoustic radialpressure wave 40) and low-frequency ultrasound waves 380 and 381, due totheir mutation, natural selection, transformation, transduction orconjugation. This can constitute a significant advantage when comparedto different chemicals and biocides, which in time triggers pathogenmutations and resistance.

The high mechanical tension and pressures found at the front of thefocused acoustic pressure shockwave distinguishes them from other kindsof sound waves, such as ultrasonic waves or pressure waves. FIG. 4presents the main and unique characteristics for the focused acousticpressure shockwave 40, which are the same regardless of the principleused to generate them. In the specific case described in FIG. 4 , theshockwaves are produced via the spark-gap electrohydraulic principle. Tofocus shockwaves, it is necessary to produce them in one point and thenfocus the shockwaves towards another point where their action is needed.The only geometry that has two focal points is the ellipse and inthree-dimensional realm is the ellipsoid (see FIGS. 7, 30 and 31 ),which is the geometry used for the reflector 42 (in other embodimentsthe reflector 42 may have other geometries besides elliptical, such asparabolic and combination semi-spherical and conical). However, for themedical field the second focal point F₂ of the ellipsoidal geometry mustcoincide with the tissue being treated or the region where theshockwaves' action is needed, which means that only a semi-ellipsoidalreflector 42 and not full ellipsoid can be used, as clearly depicted inFIGS. 4, 8, 9, 12, 17, 19, 20B, 21B, 22, and 27 ). Thus, the focusedacoustic pressure shockwave 40 are produced via discharging a highvoltage in the fluid-filled reflector cavity 43 and in between the firstelectrode 45A and second electrode 45B of the spark-gap 41, which isplaced in first focal point F₁ (FIGS. 7 and 8 ) of the semi-ellipsoidalreflector 42. The high voltage discharge produces an oscillating plasmabubble that creates kinetic energy in the fluid present in thefluid-filled reflector cavity 43. This high kinetic energy is in factthe shockwave that is then reflected by the semi-ellipsoidal reflector42 towards the second focal point 47 (F₂ from FIGS. 7, 8, 9, and 12 ).The shockwave focusing 46 is done towards a focal volume 48 that iscentered around the focal point 47 (F₂ of the ellipsoidal geometry). Tokeep the fluid inside the fluid-filled reflector cavity 43, a couplingmembrane 44 is used that stays on top of the opening/aperture of thesemi-ellipsoidal reflector 42. In the focal volume 48, produced by thefocused acoustic pressure shockwave 40, there is a special pressure “P”profile function of time “t” that defines the shockwave pressure signal49. Thus, there is a sharp increase in positive/compressive pressure tothe maximum shockwave positive pressure 49B of the shockwave compressivephase 49D, which is defined by a rise time 49A in the range of tens ofnano seconds to hundreds of nano seconds. After the positive pressure isreaching the maximum shockwave positive pressure 49B, then the pressuredecreases exponentially towards zero, which completely defines the fullshockwave compressive phase 49D of the shockwave pressure signal 49. Thepulse width 49C is defined as the time interval beginning at the firsttime the positive pressure exceeds 50% of the maximum shockwave positivepressure 49B. The larger the pulse width 49C, the larger and morepowerful is the shockwave compressive phase 49D and its influence on theendoscopes or reusable contaminated tubing from ventilators and dialysismachines or from any other medical devices, to produce biofilms and soildislodging, and elimination of infectious pathogens. Once the pressuresare in the negative values, they are in the shockwave tensile phase 49F.After reaching the maximum shockwave negative pressure 49E, the pressureis going back towards zero to completely outline the shockwave tensilephase 49F profile and also define the end of the focused shockwavepressure signal 49. During the shockwave tensile phase 49F that ischaracterized by negative pressures, cavitation bubbles can be generatedin fluids. The cavitation bubbles are gas voids in fluids that grow aslong as the energy is delivered to the bubble. This energy is releasedfrom the bubble during its collapse (implosion) in the form ofhigh-speed pressure micro jets and localized/transient high temperature.The micro jets and elevated temperature are present within the shockwavetensile phase 49F and are transient in nature. The compressivepressures, the high-speed pressure micro jets, and localized/transienthigh temperature occur with each shockwave pulse and all of them arecontributing to the cleaning and high-level disinfection process. Thetotal time duration of a shockwave pressure signal 49 is in between fiveto eight microseconds, which defines a strong and rapid pressurevariation, that produces significant, controlled, and efficient effectsduring the cleaning and high-level disinfection of the endoscopes orreusable contaminated tubing from ventilators and dialysis machines, toname a few.

Focused acoustic pressure shockwave 40 are more powerful in general anddeposit more energy in the targeted tissue when compared to pressurewaves, which are having a pressure signal flatter and more sinusoidal inshape for acoustic planar pressure wave 374 (FIG. 37 ) or pseudo-planarpressure wave 40 (slightly distorted planar waves), as presented inFIGS. 5 and 11 , and distorted tooth-shape followed by a large positivepressures region for acoustic radial pressure wave 40, as seen in FIG. 6. Due to lower positive pressures and smaller values for negativepressures for the acoustic planar pressure wave 374 or pseudo-planarpressure wave 40 or acoustic radial pressure wave 40, such pressurewaves will put less energy inside the targeted zone for cleaning andhigh-level disinfection, when compared to focused acoustic pressureshockwave 40. However, the acoustic planar pressure wave 374 orpseudo-planar pressure wave 40 or acoustic radial pressure wave 40 cancover a larger area of action, which can be advantageous in somesituation where a shorter time for the cleaning and high-leveldisinfection is paramount.

The reflectors used to create pseudo-planar pressure wave 40 areparabolic reflectors 42 characterized by only one focal point known asparabolic focal point (F), which in this situation is inside parabolicreflector 51 as presented in FIGS. 5 and 11 . The pressure waves aregenerated by the high voltage discharge in between the first electrode45A and second electrode 45B of the spark-gap 41 placed in the parabolicfocal point (F), as presented in FIGS. 5 and 11 . The high voltagedischarge produces an oscillating plasma bubble that creates kineticenergy in the fluid-filled reflector cavity 43, which actually generatesthe pressure waves. To keep the fluid inside the fluid-filled reflectorcavity 43 a coupling membrane 44 is used that stays on top of theopening/aperture of the parabolic reflector 51. These pressure waves aremoving radially from the parabolic focal point (F) in the form ofacoustic radial pressure wave 40 (see FIG. 11 ) towards the parabolicreflectors 51, which produces the pressure waves reflection 54 parallelto its longitudinal axis (similar to a flash light) and thus creatingoutside the reflector 51, the pseudo-planar pressure waves 40 inside thepseudo-planar waves pressure field 55 that overlaps with the targetedzone for cleaning and high-level disinfection. In some cases, cleanacoustic planar pressure waves 374 are created using planarpiezoelectric crystals or piezo-fibers as presented in FIG. 37 . For theacoustic planar pressure waves 374 there is no reflection involved (noreflectors needed). Since the acoustic planar pressure wave 374 orpseudo-planar pressure wave 40 are almost identical in their action andthe pressure signal shape generated in the targeted action zone, theywill be described together as a bundle. Thus, the acoustic planarpressure wave 374 (FIG. 37 ) or pseudo-planar pressure wave 40 (FIGS. 5and 11 ) are characterized by almost equal maximum planar/pseudo-planarwave positive pressure 52A and maximum planar/pseudo-planar wavenegative pressure 52C in absolute values, which makes theplanar/pseudo-planar wave pressure signal 52 from the pseudo-planarwaves pressure field 55 to have nearly a sinusoidal shape/variation forpressure “P” versus time “t”. This also means that theplanar/pseudo-planar wave compressive phase 52B and theplanar/pseudo-planar wave tensile phase 52D have similar energyincorporated in them (given by the area in between the curve and timeaxis).

The wave form of the acoustic radial pressure waves 40 is presented inFIG. 6 . In general, the acoustic radial pressure waves 40 have aduration (more than one thousand microseconds), which is more than 100times longer when compared to focused acoustic pressure shockwave 40(less than ten microseconds, or more precise in between five to eightmicroseconds). When using the electrohydraulic principle to generate theacoustic radial pressure waves 40, a high voltage discharge in betweenthe first electrode 45A and second electrode 45B of the spark-gap 41 isproduced in the sphere central point of the combination semi-sphericaland conical reflector 61. The high voltage discharge produces anoscillating plasma bubble that creates kinetic energy in thefluid-filled reflector cavity 43. To keep the fluid inside thefluid-filled reflector cavity 43 a coupling membrane 44 is used thatstays on top of the opening/aperture of the combination semi-sphericaland conical reflector 61. To not impede with the propagation of theacoustic radial pressure waves 40 generated in the sphere central point,the combination semi-spherical and conical reflector 61 has a conicalreflector portion 61B towards its mouth. The semi-spherical reflectorportion 61A reflects the acoustic radial pressure waves 40 (propagatingtowards the bottom of the combination semi-spherical and conicalreflector 61) back towards the sphere central point. That means thatthey are not contributing to the acoustic radial pressure waves 40present in the radial waves pressure field 63 that overlaps with thetargeted zone for cleaning and high-level disinfection of medicalsystems, as endoscopes 30, or parts, as reusable contaminated tubing 30(see FIG. 9 ) from ventilators and dialysis machines or from any othermedical devices, or valves, or connectors, etc. However, the reflectedportion of the acoustic radial pressure waves 40 from the bottom of thecombination semi-spherical and conical reflector 61 towards the spherecentral point will collapse any residual bubbles left in the spark-gap41 area from the plasma bubble generated by the high voltage dischargein the fluid-filled reflector cavity 43, which will allow the subsequentacoustic radial pressure waves 40 to be generated into a prettyconsistent way. In the radial waves pressure field 63, the acousticradial pressure waves 40 are characterized by a radial wave pressuresignal 64 that has distorted tooth-shape followed by a large positivepressure region. Thus, there is a sharp increase in positive/compressivepressure to the maximum radial wave positive pressure 64A of the radialwave compressive phase 64B. After the positive pressure is reaching themaximum radial wave positive pressure 64A, then the pressure decreasesalmost instantaneous towards zero, which completely defines the fullradial wave compressive phase 64B of the radial wave pressure signal 64.Once the pressures are in the negative values, they are in the radialwave tensile phase 64D. After reaching the maximum radial wave negativepressure 64C, the pressure is going back towards zero to completelyoutline the radial wave tensile phase 64D profile. However, thepressures continue to increase and become positive again and reachmaximum remnant positive pressure 64E, which is smaller when compared tothe maximum radial wave positive pressure 64A. After the positivepressure is reaching the maximum remnant positive pressure 64E, then thepressure decreases slowly towards zero, which completely defines thefull remnant positive pressure phase 64F and the end of the radial wavepressure signal 64. The positive pressure phase 64F incorporates asignificant portion of the radial wave pressure signal 64 and alsocollapses prematurely the cavitation bubbles generated in the radialwave tensile phase 64D, which means that the role played by cavitationis reduced when compared to the focused acoustic pressure shockwave 40and pseudo-planar pressure wave 40. However, some cavitation is stillproduced and the double positive pressures (maximum radial wave positivepressure 64A and maximum remnant positive pressure 64E) are enhancingthe removal of soiling, such as included contaminating particulates andparticulate matter, planktonic bacteria, virus spores, fungi, andbiofilms from the endoscopes or reusable contaminated tubing fromrespirators or hemodialysis units or any other medical devices or theirparts that requires reprocessing for cleaning and high-leveldisinfection.

FIG. 38A presents the wave form of the main ultrasound waves 380 orsecondary ultrasound waves 381 seen in FIG. 38B. In general, theultrasound waves 380 or 381 have two components. The ultrasoundlongitudinal wave 387 is the one moving in the ultrasound direction ofpropagation 389. Adjacent layers of fluid are subjected to a cycliccompression and expansion with velocity dependent on propagation media(liquid, air or solid). Coexisting with the ultrasound longitudinal wave387 is the ultrasound transversal wave 388, which is a low velocity andhigh damping wave with a sinusoidal variation in a directionperpendicular to the ultrasound direction of propagation 389. Usually,the ultrasound transversal wave 388 can produce friction in propagationmedia and consequently possible heat. However, the low-frequencyultrasound has a large ultrasound wavelength 387A that is characterizingthe ultrasound cycle 388B and this is why the effects of the ultrasoundtransversal wave 388 are less pronounced, which means that negligible orno heat is produced. Other important parameters that define theultrasound waves 380 or 381 are the ultrasound maximum positive pressure388C and ultrasound maximum negative pressure 388D, which are equal inabsolute value that is also known as ultrasound amplitude 388A. Thepositive pressures 388C produce compressive forces/stresses and thenegative pressure 388D generate cavitation bubbles. Due to continuoussequence of phases for ultrasound waves, the pressures are changing frompositive pressures to negative pressures and then again to positivepressures in a sinusoidal variation, which has a significant influenceon the cavitation. Thus, the cyclical acoustic wave of the ultrasound,make the cavitation bubbles to grow and then collapse due to incomingnew positive pressures in a cyclical way too. In general, the ultrasoundcavitation bubbles need many ultrasound cycles to reach a dimension thatallow them to collapse by themselves. Usually, the ultrasound cavitationbubbles do not reach the same size as the shockwave cavitation bubbles,which translates in less energy generated during their collapse. Also,due to continuous oscillation in dimensions, the ultrasound cavitationbubbles accumulate heat and when finally reach the appropriate dimensionthey collapse as a hot spot, which can contribute together with themicro-jets generated during collapse to the contamination materialdislodging from instruments surfaces and also to the pathogens killing.

In conclusion, as seen from FIGS. 4, 5, 6, 37, and 38A, the focusedacoustic pressure shockwaves 40 behave similarly to other sound waves(acoustic planar pressure wave 374 or pseudo-planar pressure wave 40 oracoustic radial pressure wave 40 or ultrasound waves 380 and 381), withthe main difference that the focused acoustic pressure shockwaves 40possess more energy. A focused acoustic pressure shockwave 40 can travellarger distances easily (based on the amount of energy put in them atthe point of origination), as long as the acoustic impedance of themedium remains the same. The same acoustic impedance principle is validfor pressure waves (acoustic planar pressure wave 374 or pseudo-planarpressure wave 40 or acoustic radial pressure wave 40) and low-frequencyultrasound waves 380 and 381, with the caviar that their energy issmaller when compared with focused acoustic pressure shockwaves 40 withconsequences on their relatively limited traveling distance/penetrationinside the targeted region. At the point where the acoustic impedancechanges, energy is released and the focused acoustic pressure shockwaves40 or pressure waves (acoustic planar pressure waves 374 orpseudo-planar pressure waves 40 or acoustic radial pressure waves 40)and low-frequency ultrasound waves 380 and 381 are reflected ortransmitted with attenuation. Thus, the difference in between shockwavesand pressure waves or ultrasound is the amount of energy they depositinside the targeted zone and sometimes their penetration inside the sametargeted zone. Shockwaves are more powerful in general and have moreenergy due to their higher compressive pressures produced in thecompressive phase and larger negative pressure from the tensile phase,which can produce more powerful cavitation bubbles in a fluid (see FIGS.4, 5, 6, and 38A). On their turn, the pressure waves and low-frequencyultrasound are having a pressure signal flatter, more sinusoidal inshape, and due to their lower positive pressures and smaller values fornegative pressures that influences the size of cavitation bubbles, theywill put less energy inside the targeted zone. Sometimes this lowerenergy can be beneficial for specific applications where the targeteddevice, or system, or sub-component, or part have a more delicateconstruction.

FIG. 7 presents the typical ellipsoidal geometry that is used forfocusing shockwaves. The ellipse 70 is the only geometry that has twofocal points, which means that whatever is generated in the first focalpoint F₁ can be reflected and focused in the second focal point F₂.Based on this property, if a form of energy carrier is produced in F₁via a high voltage discharge in a fluid using a spark-gap 41, it can bereflected and finally concentrated in the second focal point F₂, definedas the focal point 47. That is practically the way that focused acousticpressure shockwaves 40 are generated and focused towards a targetedregion that sits around the second focal point F₂. The ellipticalgeometry is characterized by the major elliptical semi axis “c”, minorelliptical semi axis “b”, and their ratio, which dictates the actualellipse length and width, with significant implications on thereflective properties of a potential reflector with that specificgeometry.

FIG. 8 is a geometric representation of the classic semi-ellipsoidalreflector 42, which is usually used to produce and reflect focusedelectrohydraulic shockwaves. Since the cleaning and high-leveldisinfection with focused acoustic pressure shockwaves 40 is produced inthe focal volume 48 that encompasses the second focal point F₂ (definedas focal point 47), only a portion of the ellipsoidal geometry can beused for focusing. In most of the cases half of the ellipsoidal geometrycan be used and those are the classic semi-ellipsoidal reflectors 42.When the endoscopes or reusable contaminated tubing from respirators orhemodialysis units or any other medical devices or their parts areplaced before or after the focal volume 48, then the cleaning andhigh-level disinfection is produced by unfocused pressure waves. Thesemi-ellipsoidal reflector 42 can be shallow or deep, based on the ratioof the major elliptical semi axis “c” and minor elliptical semi axis“b”. If the ration c/b is higher than 1.9 (c/b>1.9), then thesemi-ellipsoidal reflector 42 is considered to be deep. With a ratio of1.1≤c/b≤1.3 the semi-ellipsoidal reflector 42 is considered shallow andfor 1.3<c/b≤1.9 is considered normal. The first focal point F₁ of thesemi-ellipsoidal reflector 42 is where the shockwaves are generated viaspark-gap 41 for the electrohydraulic principle that uses two electrodes(first electrode 45A and second electrode 45B) to produce a high voltagedischarge in a fluid. The shockwave focusing 46 is done by the internalsurface of the classic semi-ellipsoidal reflector 42 towards the focalpoint 47 (second focal point F₂) and the surrounded focal volume 48, aspresented also in FIG. 4 . To keep the fluid inside the fluid-filledreflector cavity 43 a coupling membrane 44 is used that stays on top ofthe opening/aperture of the semi-ellipsoidal reflector 42. Theseelements and construction presented in FIGS. 7 and 8 for thesemi-ellipsoidal reflector 42 will be found in many of the embodimentspresented in FIGS. 9, 12, 17A-17B, 19A-23, and 27 .

It is an objective of the present inventions to provide differentmethods of generating focused shockwaves or special high-intensitypressure waves (planar, pseudo-planar, radial, or unfocused waves) orlow-frequency ultrasound for cleaning and high-level disinfection ofendoscopes or reusable contaminated tubing from ventilators and dialysismachines, or other reusable parts for medical systems, as follows:

-   -   electrohydraulic generators using high voltage discharges (FIGS.        9-11, 17A-36, 39, and 41-46B)    -   electrohydraulic generators using one or multiple laser sources        (FIGS. 12, 23, and 40 , and they can be also used with specific        modifications for FIGS. 17A-36, and 41-46B)    -   piezoelectric generators using piezo crystals/piezo ceramics        (FIGS. 15, 37, and 38A-38B, and they can be also used with        specific modifications for FIGS. 17A-36 , and 41-46B)    -   piezoelectric generators using piezo fibers (FIGS. 16, 37,        38A-38B, and they can be also used with specific modifications        for FIGS. 17A-36, and 41-46 )    -   electromagnetic generators using a flat coil (FIG. 14 and they        can be also used with specific modifications for FIGS. 17A-24,        27-36, and 41-46 )    -   electromagnetic generators using a cylindrical coil (FIG. 13 and        they can be also used with specific modifications for FIGS.        17A-24, 27-36, and 41-46 )

For some of the figures mentioned above, although one of theprinciple/method of waves generation is specifically presented in thefigure, other methods may also apply, based on each embodimentconstruction. That it will be mentioned for each figure where suchsituation applies.

In general, the energy is delivered for all embodiments presented inthis invention from a power supply in the form of high voltage settingfor electrohydraulic and piezoelectric devices and electrical currentsetting for electromagnetic devices and ultrasonic devices. The powersupply functionality and the parameters of the cleaning and high-leveldisinfection process performed by the decontamination system iscontrolled by a control console/unit, designed to have processors andmicroprocessors, displays, input/output elements, timers, memory units,remote control devices, independent power unit, etc. Each of thesecomponents may include hardware, software, or a combination of hardwareand software configured to perform one or more functions associated withproviding good functioning of the whole decontamination system thatemploys the use of the focused acoustic pressure shockwaves or pressurewaves (acoustic planar pressure waves or pseudo-planar pressure waves oracoustic radial pressure waves) and low-frequency ultrasound waves.

Sometimes combination geometries ca be used for the reflectors mentionedin the present inventions. Two or more geometries can be used (portionof an ellipsoid, combined with a portion of a sphere and a portion of aparaboloid). That can have an effect on the way the shockwaves orpressure waves are reflected, how many focal volumes are created thatcan overlap or can be totally separated, and finally the actual focalvolume shape and its position in space.

Non-rotational reflector geometries can be also used to reflectshockwaves or pressure waves. In this case, the reflector can have apyramid geometry with triangle, square, hexagonal, or octagonalaperture. In other situations, no reflectors are used at all, wheremultiple spark-gap or laser electrohydraulic sources are used (see FIGS.39 and 40 ) or simply flat piezo-crystals (FIGS. 37 and 38B) or flatpiezofibers composites (FIG. 37 ). In these cases, a planar pressurewave or a radial pressure wave or an ultrasound wave is crated thatmoves in any direction or preferred directions.

The embodiments of the present inventions that are used to clean anddisinfected endoscopes or reusable contaminated/tubes from respirators,hemodialysis units and any other medical devices, are further describedin detail in the following paragraphs.

In FIG. 9 presents a decontamination system 90 using the focusedacoustic pressure shockwaves 40 that are generated via high voltagedischarge produced in between first electrode 45A and the secondelectrode 45B (electrohydraulic principle using spark gap high voltagedischarges) in a fluid present inside the reflector cavity 43. The highvoltage for the first electrode 45A and the second electrode 45B isprovided by the power supply 95 (included in control console/unit 96)via high voltage cable 94. The two electrodes 45A and 45B are positionedin the first focal point F₁ (forming the spark-gap 41, as presented inFIG. 4 ) of the semi-ellipsoidal reflector 42. During high voltagedischarge a plasma bubble is generated that expands and collapsestransforming the heat into kinetic energy in the form of acousticpressure shockwaves that reflect on the semi-ellipsoidal reflector 42,and through shockwave focusing 46 are producing the focused acousticpressure shockwaves 40, which are directed through theapplicator/coupling membrane 44 towards the focal point 47 (F₂ of theellipsoidal geometry) and overall to the focal volume 48 that overlapswith the targeted cleaning and high-level disinfection region where theendoscope 30 or reusable contaminated tubing 30 is present. To be ableto properly/completely overlap the focal volume 48 with the endoscope 30or reusable contaminated tubing 30, the transversal (T) and longitudinal(L) motions of the applicator 97 are performed manually by the operatoror by using semi-automatic or automatic means. Since the focusedacoustic pressure shockwaves 40 are produced in a liquid medium, inorder to not lose energy through reflections at the change of acousticimpedance from one medium to another and fully take advantage of themicro-jets produced by the collapse of cavitation bubbles, the endoscope30 or the reusable contaminated tubing 30 are placed into liquid bath 93and their lumen/lumens filled with a decontamination fluid 205 (seeFIGS. 20B and 21B).

To assure the complete cleaning and decontamination on the full lengthof medical devices such as endoscopes 30, or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices, either the contaminated device/part needs to moveor alternatively the applicator 97 moves and sometimes both. In FIG. 9the movement of an endoscope 30, or reusable contaminated tubing 30 fromrespirators or hemodialysis units or from any other medical devices, infront of the focused acoustic pressure shockwaves 40 can be donemanually or automatic via a motorized system, which assures the completeexposure of the entire contaminated areas, regardless of the device/partlength. This is why the endoscopes 30, or the reusable contaminatedtubing 30 (tubes) from respirators, hemodialysis units, and any othermedical devices are moving in the tubing/endoscope moving direction 92and in front of the focused acoustic pressure shockwaves 40.

In the embodiment from FIG. 10 the decontamination system 90 is using acombination semi-spherical and cylindrical reflector 100 that sendsacoustic radial pressure waves 40 towards the endoscope 30 or reusablecontaminated tubing 30. The acoustic pressure wave applicator 97 isproducing the acoustic radial pressure waves 40 in the center F ofsemi-spherical reflector portion 100A of the combination semi-sphericaland cylindrical reflector 100 that has in its upper part the cylindricalreflector portion 100B above the plane of the central point F andslightly tapered at the aperture (reflector's opening). Theapplicator/coupling membrane 44 sits at the aperture/opening of thecombination semi-spherical and cylindrical reflector 100 and thuscreating a fluid-filled reflector cavity 43. The “direct” acousticradial pressure waves 40 are generated via the high voltage dischargebetween first electrode 45A and second electrode 45B and they travelfrom the center F of semi-spherical reflector portion 100A through theaperture of the acoustic pressure wave applicator 97 andapplicator/coupling membrane 44 directly to the endoscope 30 or reusablecontaminated tubing 30 without any reflection. The high voltage for thefirst electrode 45A and the second electrode 45B is provided by thepower supply 95 (included in control console/unit 96) via high voltagecable 94. Due to the special construction of the combinationsemi-spherical and cylindrical reflector 100, the spheric waves/radialwaves that are reaching the reflecting surface of the combinationsemi-spherical and cylindrical reflector 100 are reflected back towardsthe spherical center F or the longitudinal axis of the reflector. Thisavoids unnecessary reflected radial waves to be directed towards theendoscope 30 or reusable contaminated tubing 30 that can interfere withthe “direct” acoustic radial pressure waves 40. Since the “direct”acoustic radial pressure waves 40 are produced in a liquid medium, inorder to not lose energy through reflections at the change of acousticimpedance from one medium to another and fully take advantage of themicro jets produced by the collapse of cavitation bubbles, the endoscope30 or the reusable contaminated tubing 30 are placed into liquid bath 93and their lumen/lumens filled with a decontamination fluid 205 (seeFIGS. 20B and 21B). By their nature, the “direct” acoustic radialpressure waves 40 (exiting through the aperture of the combinationsemi-spherical and cylindrical reflector 100) are unfocused and thusthey move through the radial waves pressure field 63 (seen in FIG. 6 )and through the endoscope 30 or reusable contaminated tubing 30 withoutbeing able to be concentrated/focused in a certain focal region, as seenbefore for the focused acoustic pressure shockwaves 40 (schematicallyshown in FIGS. 4, 8, and 9 ). Another way to create acoustic radialpressure waves 40 is given by ballistic devices that use pneumatics topush at high speeds a small cylindrical piece (bullet) against a platethat vibrates (due to the impact of the bullet) and thuscreating/generating acoustic radial pressure waves 40. The ballisticdevices were not specifically depicted in any of the figures of thisinvention, but can be used to generate acoustic radial pressure waves40. To be able to properly overlap the acoustic radial pressure waves 40with the reusable contaminated tubing 30, the transversal (T) andlongitudinal (L) motions of the applicator 97 are performed manually bythe operator or by using semi-automatic or automatic means.

To assure the complete cleaning and decontamination on the full lengthof medical devices such as endoscopes 30, or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices, either the contaminated device/part needs to moveor alternatively the applicator 97 moves and sometimes both, usingmanually or motorized automatic means. In FIG. 10 the endoscope 30, orreusable contaminated tubing 30 from respirators or hemodialysis unitsor from any other medical devices is moving in the tubing/endoscopemoving direction 92 and in front of the acoustic radial pressure waves40.

In the embodiment shown in FIG. 11 the decontamination system 90 isusing a parabolic reflector 51 that sends pseudo-planar pressure waves40 outside the applicator/coupling membrane 44 and through the endoscope30 or reusable contaminated tubing 30. The parabolic reflector 51 hasonly a central point/focus point F (parabolic focal point) where radialacoustic pressure waves 40 are generated (via the high voltage dischargebetween first electrode 45A and second electrode 45B in the liquidpresent inside the reflector cavity 43). The acoustic radial pressurewaves 40 propagate and reflect on the parabolic reflector 51 atdifferent time points, which creates secondary pressure wave fronts (notshown on FIG. 11 to keep clarity), especially at the edge/aperture ofthe parabolic reflector 51. The combination of direct acoustic radialpressure waves 40 with the secondary pressure wave fronts createspseudo-planar pressure waves 40 outside the applicator/coupling membrane44, forming the pseudo-planar waves pressure field 55 (as seen in FIG. 5). In this case presented in FIG. 11 , the parabolic focal point F ispresent inside the parabolic reflector 51 of the applicator 97 and thisis why pseudo-planar pressure waves 40 are produced outside theapplicator/coupling membrane 44 and pass through the endoscope 30 orreusable contaminated tubing 30. This is different from the embodimentspresented in FIGS. 13-16 , where the parabolic focal point F is outsidethe parabolic reflector 51 of the applicator 97 and it is overlappingwith the longitudinal axis of the endoscope 30 or reusable contaminatedtubing 30. This is why the embodiments from FIGS. 13-16 produce focusedacoustic pressure shockwaves 40 outside the applicator/coupling membrane44 that are passing through the endoscope 30 or reusable contaminatedtubing 30.

By their nature, the pseudo-planar pressure waves 40 (exiting throughthe aperture of the parabolic reflector 51 and the applicator/couplingmembrane 44) are unfocused and thus they move away from their point oforigin F (parabolic focal point) without being able to be concentratedin a certain focal region, as seen for the focused acoustic pressureshockwaves 40 (shown in FIGS. 9, 13-19, 23-24, 25A, 25B, 31, and 32 ).The action of the pseudo-planar pressure waves 40 outside theapplicator/coupling membrane 44 is controlled by the input energy,delivered via the cable 94 from the power supply 95 that is controlledby the control console/unit 96. To be able to perform properly thecleaning and high-level disinfection process, the pseudo-planar wavespressure field 55 (see FIG. 5 ), produced outside theapplicator/coupling membrane 44 by the pseudo-planar pressure waves 40,needs to overlap with the endoscope 30 or reusable contaminated tubing30. To accomplish that the transversal (T) and longitudinal (L) motionsof the applicator 97 are performed manually by the operator or by usingsemi-automatic or automatic means. Since the pseudo-planar pressurewaves 40 are produced in a liquid medium, in order to not lose energythrough reflections at the change of acoustic impedance from one mediumto another and fully take advantage of the micro jets produced by thecollapse of cavitation bubbles, the endoscope 30 or the reusablecontaminated tubing 30 are placed into liquid bath 93 and theirlumen/lumens filled with a decontamination fluid 205 (see FIGS. 20B and21B).

To assure the complete cleaning and decontamination on the full lengthof medical devices such as endoscopes 30 or of the reusable contaminatedtubing 30 from respirators, hemodialysis units and any other medicaldevices, either the contaminated device/part needs to move oralternatively the applicator 97 moves and sometimes both, using manuallyor motorized automatic means. In FIG. 11 the endoscope 30, or reusablecontaminated tubing 30 from respirators or hemodialysis units or fromany other medical devices is moving in the tubing/endoscope movingdirection 92 and in front of the pseudo-planar pressure waves 40.

In FIG. 12 the decontamination system 90 is using the focused acousticpressure shockwaves 40 that are generated via one or multiple lasersources (electrohydraulic principle using one or multiple laserssources). In this specific case, the laser beams produced by firstincased laser 45C and the second incased laser 45D in a fluid presentinside the reflector cavity 43 generate the acoustic pressure shockwaves40, which are then focused via semi-ellipsoidal reflector 42 towards thefocal point 47 (F₂ of the ellipsoidal geometry) and overall, to thefocal volume 48 that overlaps with endoscope 30 or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices. The high voltage for the first incased laser 45Cand the second incased laser 45D is provided by the power source 95(included in control/console unit 96) via high voltage cable 94. The twolaser sources are positioned in such way to intersect their beams in thefirst focal point F₁ of the semi-ellipsoidal reflector 42 in order toproduce a plasma bubble that expands and collapses transforming the heatinto kinetic energy in the form of acoustic pressure shockwaves thatreflect on the semi-ellipsoidal reflector 42, and through shockwavefocusing 46 are producing the focused acoustic pressure shockwaves 40,which are directed towards the focal point 47 (F₂ of the ellipsoidalgeometry) and overall to the focal volume 48 that overlaps with thetargeted cleaning and high-level disinfection region where the endoscope30 or reusable contaminated tubing 30 is present. FIG. 12 includes ameans of monitoring the system performance by measuring the reactiontemperature of the plasma bubble collapse using a method of opticalfiber thermometry. An optical fiber tube assembly 120 extends into theF₁ region of the semi-ellipsoidal reflector 42. The optical fiber tubeassembly 120 transmits (via optical fiber 121) specific spectralfrequencies created from the sonoluminescence of the plasma bubblereaction in the fluid present inside the reflector cavity 43 to thespectral analyzer 122. The loop is closed via feedback cable 123 thatconnects the spectral analyzer 122 with the power supply 95. Basically,the spectral analysis provided by the spectral analyzer 122 is used toadjust accordingly the power generated by the power supply 95, to ensurea proper laser discharge for the incased lasers 45C and 45D. To be ableto properly overlap the focal volume 48 with the endoscope 30 orreusable contaminated tubing 30, the transversal (T) and longitudinal(L) motions of the applicator 97 are performed manually by the operatoror by using semi-automatic or automatic means. Since the focusedacoustic pressure shockwaves 40 are produced in a liquid medium, inorder to not lose energy through reflections at the change of acousticimpedance from one medium to another and fully take advantage of themicro-jets produced by the collapse of cavitation bubbles, the endoscope30 or the reusable contaminated tubing 30 are placed into liquid bath 93and their lumen/lumens filled with a decontamination fluid 205 (seeFIGS. 20B and 21B).

To assure the complete cleaning and decontamination on the full lengthof medical devices such as endoscopes 30, or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices, either the contaminated device/part needs to moveor alternatively the applicator 97 moves and sometimes both, usingmanually or motorized automatic means. In FIG. 12 the endoscope 30, orreusable contaminated tubing 30 from respirators or hemodialysis unitsor from any other medical devices is moving in the tubing/endoscopemoving direction 92 and in front of the focused acoustic pressureshockwaves 40.

In FIGS. 9 and 12 , where the electrohydraulic principle is used toproduce focused acoustic pressure shockwaves 40, if the semi-ellipsoidalreflector 42 is replaced with a parabolic reflector 51 (see FIG. 5 )that has its parabolic focal point (F) in the same position as the firstfocal point (F₁) of the semi-ellipsoidal reflector 42, then theapplicator 97 will produce pseudo-planar pressure waves 40, similar tothose from the embodiment presented in FIG. 11 .

In FIG. 13 the decontamination system 90 is using the focused acousticpressure shockwaves 40 that are generated via electromagneticcylindrical coil and tube assembly 4511 (electromagnetic principle usinga cylindrical coil). In this case, an electromagnetic cylindrical coilis excited by a short electrical pulse provided by the power supply 95(included in control console/unit 96) via high voltage cable 94, and theplate is in the shape of a tube (thus creating an electromagneticcylindrical coil and tube assembly 4511), which will results in acylindrical pressure wave (not shown in FIG. 13 ) that can be focused bya parabolic reflector 51 (shockwave focusing 46) towards the parabolicfocal point 47 (F) and overall, to the focal volume 48. When theelectromagnetic cylindrical coil is excited by a short electrical pulseprovided by the power supply 95 (included in control console/unit 96)via high voltage cable 94, the cylindrical coil experiences a repulsiveforce and this is used to generate a cylindrical acoustic pressure waveinside the fluid-filled reflector cavity 43 that is reflected on theparabolic reflector 51, thus creating focused acoustic pressureshockwaves 40.

Conversely, in another embodiment the parabolic reflector 51 can bereplaced by a semi-ellipsoidal reflector 42 to create unfocused pressurewaves that generate a pressure field outside the applicator/couplingmembrane 44 of the semi-ellipsoidal reflector 42, pressure field thatneeds to overlap with the endoscope 30 or reusable contaminated tubing30, to produce their cleaning and decontamination.

To be able to perform properly the cleaning and high-level disinfectionprocess, the endoscope 30 or reusable contaminated tubing 30 needs tooverlap with the focal volume 48 (for focused acoustic pressureshockwaves 40) or the pressure field produced outside theapplicator/coupling membrane 44 by unfocused pressure waves, when theparabolic reflector 51 is replaced by a semi-ellipsoidal reflector 42.To accomplish that, the transversal (T) and longitudinal (L) motions ofthe applicator 97 are performed manually by the operator or by usingsemi-automatic or automatic means. For FIG. 13 , since the focusedacoustic pressure waves 40 are produced in a liquid medium, in order tonot lose energy through reflections at the change of acoustic impedancefrom one medium to another and fully take advantage of the micro-jetsproduced by the collapse of cavitation bubbles, the endoscope 30 or thereusable contaminated tubing 30 are placed into liquid bath 93 and theirlumen/lumens filled with a decontamination fluid 205 (see FIGS. 20B and21B).

To assure the complete cleaning and decontamination on the full lengthof medical devices such as endoscopes 30, or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices, either the contaminated device/part needs to moveor alternatively the applicator 97 moves and sometimes both, usingmanually or motorized automatic means. In FIG. 13 the endoscope 30, orreusable contaminated tubing 30 from respirators or hemodialysis unitsor from any other medical devices is moving in the tubing/endoscopemoving direction 92 and in front of the focused acoustic pressureshockwaves 40.

In FIG. 14 the decontamination system 90 is using the focused acousticpressure shockwaves 40 that are generated via electromagnetic flat coiland plate assembly 45G and an acoustic lens 140 (electromagneticprinciple using a flat coil and an acoustic lens). In this case, anelectromagnetic flat coil is placed in close proximity to a metal platethat acts as an acoustic source and thus the electromagnetic flat coiland plate assembly 45G presented in FIG. 14 is created. When theelectromagnetic flat coil is excited by a short electrical pulseprovided by the power supply 95 (included in control console/unit 96)via high voltage cable 94, the plate experiences a repulsive force andthis is used to generate an acoustic pressure wave. Due to the fact thatthe metal plate is flat, the resulting acoustic pressure wave is aplanar acoustic pressure wave (not shown in FIG. 14 ) that is moving inthe fluid-filled cavity 141 towards the acoustic lens 140, which isfocusing the planar wave (shockwave focusing 46) and thus creating thefocused acoustic pressure shockwaves 40. The focusing effect of theacoustic lens 140 is given by its shape, which as presented in FIG. 14is a portion of a parabolic surface. This is why the acoustic lens 140is used in tandem with a parabolic reflector 51 that can help with thefocusing of the produced focused acoustic pressure shockwaves 40 towardsthe parabolic focal point 47 (F) and overall, to the focal volume 48.

Conversely, in another embodiment the acoustic lens 140 can be a portionof an ellipsoidal surface and in combination with a semi-ellipsoidalreflector 42 can create unfocused pressure waves that can generate apressure field outside the applicator/coupling membrane 44 of thesemi-ellipsoidal reflector 42, pressure field that needs to overlap withthe endoscope 30 or reusable contaminated tubing 30, to produce theircleaning and decontamination.

To be able to perform properly the cleaning and high-level disinfectionprocess, the endoscope 30 or reusable contaminated tubing 30 needs tooverlap with the focal volume 48 (for focused acoustic pressureshockwaves 40) or the pressure field produced outside theapplicator/coupling membrane 44 by unfocused pressure waves, when theparabolic reflector 51 is replaced by a semi-ellipsoidal reflector 42.To accomplish that the transversal (T) and longitudinal (L) motions ofthe applicator 97 are performed manually by the operator or by usingsemi-automatic or automatic means. For FIG. 14 , since the focusedacoustic pressure waves 40 are produced in a liquid medium, in order tonot lose energy through reflections at the change of acoustic impedancefrom one medium to another and fully take advantage of the micro-jetsproduced by the collapse of cavitation bubbles, the endoscope 30 or thereusable contaminated tubing 30 are placed into liquid bath 93 and theirlumen/lumens filled with a decontamination fluid 205 (see FIGS. 20B and21B).

To assure the complete cleaning and decontamination on the full lengthof medical devices such as endoscopes 30, or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices, either the contaminated device/part needs to moveor alternatively the applicator 97 moves and sometimes both, usingmanually or motorized automatic means. In FIG. 14 the endoscope 30, orreusable contaminated tubing 30 from respirators or hemodialysis unitsor from any other medical devices is moving in the tubing/endoscopemoving direction 92 and in front of the focused acoustic pressureshockwaves 40.

In FIG. 15 the decontamination system 90 is using the focused acousticpressure shockwaves 40 that are generated via piezo crystals/piezoceramics 45E (piezoelectric principle using piezo crystals/piezoceramics). In this case, the internal generation of a mechanical strainresulting from an applied electrical field to the piezo crystal s/piezoceramics 45E, which are uniformly placed on a parabolic reflector 51,generate in a fluid present inside the reflector cavity 43 the focusedacoustic pressure shockwaves 40. The parabolic reflector 51 produces theshockwave focusing 46 towards its focal point F (parabolic focal point47) and overall, to the focal volume 48. To accomplish the shockwavefocusing 46, all the surface of the parabolic reflector 51 is covered bythe piezo crystals/piezo ceramics 45E. The electrical field for thepiezo crystals/piezo ceramics 45E is provided by the power supply 95(included in control console/unit 96) via high voltage cable 94.

Relatively similar effects can be accomplished when the piezocrystals/piezo ceramics 45E are used together with the semi-ellipsoidalreflector 42. In this case, since the pressure waves are originatingfrom the surface of the semi-ellipsoidal reflector 42 and not from thefocal point F₁ of the ellipsoidal geometry, the produced pressure wavesfall more in the category of unfocused pressure waves and notshockwaves. The unfocused pressure waves can generate a pressure fieldoutside the applicator/coupling membrane 44 of the semi-ellipsoidalreflector 42, pressure field that needs to overlap with the endoscope 30or reusable contaminated tubing 30, to produce their cleaning anddecontamination.

To be able to perform properly the cleaning and high-level disinfectionprocess, the endoscope 30 or reusable contaminated tubing 30 needs tooverlap with the focal volume 48 (for focused acoustic pressureshockwaves 40) or the pressure field produced outside theapplicator/coupling membrane 44 by unfocused pressure waves, when theparabolic reflector 51 is replaced by a semi-ellipsoidal reflector 42.To accomplish that, the transversal (T) and longitudinal (L) motions ofthe applicator 97 are performed manually by the operator or by usingsemi-automatic or automatic means. For FIG. 15 , since the focusedacoustic pressure waves 40 are produced in a liquid medium, in order tonot lose energy through reflections at the change of acoustic impedancefrom one medium to another and fully take advantage of the micro-jetsproduced by the collapse of cavitation bubbles, the endoscope 30 or thereusable contaminated tubing 30 are placed into liquid bath 93 and theirlumen/lumens filled with a decontamination fluid 205 (see FIGS. 20B and21B).

To assure the complete cleaning and decontamination on the full lengthof medical devices such as endoscopes 30, or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices, either the contaminated device/part needs to moveor alternatively the applicator 97 moves and sometimes both, usingmanually or motorized automatic means. In FIG. 15 the endoscope 30, orreusable contaminated tubing 30 from respirators or hemodialysis unitsor from any other medical devices is moving in the tubing/endoscopemoving direction 92 and in front of the focused acoustic pressureshockwaves 40.

Due to the parallelepiped or cylindrical geometry of the piezocrystals/piezo ceramics 45E, they may not fit very well to the parabolicreflector 51 surface, which can create problems with focusing towardsthe parabolic focal point 47 (F), especially in situations where deeppenetrations are needed, since these geometries will require a sharpvertex of the parabola with smaller radiuses that are difficult to coverwith parallelepiped or cylindrical piezo crystals/piezo ceramics 45E. Toovercome this issue, the piezo crystals/piezo ceramics 45E can bereplaced by piezo fibers in the construction of a decontamination system90, as presented in FIG. 16 . The piezo fibers can be integrated in acomposite material with their longitudinal axis perpendicular to a solidsurface as the parabolic reflector 51, thus forming a piezo fiber layer45F capable of producing focused acoustic pressure shockwaves 40. Theadvantage of the piezo fiber layer 45F when compared to the piezocrystals/piezo ceramics 45E is that the smaller dimension andcylindrical geometry (hair-like geometry) of the piezo fibers allowsthem to fit significantly better to the parabolic or ellipsoidalgeometries. Furthermore, the electric contacting of the piezo fibers maybe realized by a common electrically conductive layer according to theinterconnection requirements. Hence, the complex interconnection of amultitude of piezo crystals/piezo ceramics 45E (as presented in FIG. 16) is no longer required. When an electrical field is provided by thepower supply 95 (included in control console/unit 96) via high voltagecable 94 to the piezo fiber layer 45F, the piezo electric fibers willstretch in unison mainly in their lengthwise direction, which willcreate focused acoustic pressure shockwaves 40 from the surface of theparabolic reflector 51 that is producing shockwave focusing 46 towardsthe parabolic focal point 47 (F) and overall, to the focal volume 48.

Relatively similar effects can be accomplished when the piezo fiberlayer 45F is used together with a semi-ellipsoidal reflector 42, but inthis case since the pressure waves are originating from the surface ofthe semi-ellipsoidal reflector 42 and not from the focal point F₁ of theellipsoidal geometry, and thus the produced pressure waves fall more inthe category of unfocused waves and not shockwaves. The unfocusedpressure waves can generate a pressure field outside theapplicator/coupling membrane 44 of the semi-ellipsoidal reflector 42,pressure field that needs to overlap with the endoscope 30 or reusablecontaminated tubing 30, to produce their cleaning and decontamination.

To be able to perform properly the cleaning and high-level disinfectionprocess, the endoscope 30 or reusable contaminated tubing 30 needs tooverlap with the focal volume 48 (for focused acoustic pressureshockwaves 40) or the pressure field produced outside theapplicator/coupling membrane 44 by unfocused pressure waves, when theparabolic reflector 51 is replaced by a semi-ellipsoidal reflector 42.To accomplish that, the transversal (T) and longitudinal (L) motions ofthe applicator 97 are performed manually by the operator or by usingsemi-automatic or automatic means. For FIG. 16 , since the focusedacoustic pressure waves 40 are produced in a liquid medium, in order tonot lose energy through reflections at the change of acoustic impedancefrom one medium to another and fully take advantage of the micro-jetsproduced by the collapse of cavitation bubbles, the endoscope 30 or thereusable contaminated tubing 30 are placed into liquid bath 93 and theirlumen/lumens filled with a decontamination fluid 205 (see FIGS. 20B and21B).

To assure the complete cleaning and decontamination on the full lengthof medical devices such as endoscopes 30, or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices, either the contaminated device/part needs to moveor alternatively the applicator 97 moves and sometimes both, usingmanually or motorized automatic means. In FIG. 16 the endoscope 30, orreusable contaminated tubing 30 from respirators or hemodialysis unitsor from any other medical devices is moving in the tubing/endoscopemoving direction 92 and in front of the focused acoustic pressureshockwaves 40.

The embodiment from FIGS. 17A and 17B shows how a manual or asemi-automatic system using one applicator 97 can be used to produce thecleaning and decontamination of endoscopes 30 or of the reusablecontaminated tubing 30 using the focused acoustic pressure shockwaves40. The decontamination system 90 is using the focused acoustic pressureshockwaves 40 that are generated via high voltage discharge produced inbetween first electrode 45A and the second electrode 45B(electrohydraulic principle using spark gap high voltage discharges) ina fluid present inside the reflector cavity 43. The high voltage for thefirst electrode 45A and the second electrode 45B is provided by thepower supply 95 (included in control console/unit 96) via high voltagecable 94. The two electrodes 45A and 45B are positioned in the firstfocal point F₁ (forming the spark-gap 41, as presented in FIG. 4 ) ofthe semi-ellipsoidal reflector 42. During high voltage discharge aplasma bubble is generated that expands and collapses transforming theheat into kinetic energy in the form of acoustic pressure shockwavesthat reflect on the semi-ellipsoidal reflector 42, producing the focusedacoustic pressure shockwaves 40, which are directed through theapplicator/coupling membrane 44 towards the focal point F₂ of theellipsoidal geometry and overall to the focal volume 48 that overlapswith the targeted cleaning and high-level disinfection region where theendoscope 30 or reusable contaminated 30 is present. To be able toproperly overlap the focal volume 48 with the endoscope 30 or reusablecontaminated tubing 30, the transversal (T) and longitudinal (L) motionsof the applicator 97 are performed manually by the operator or by usingsemi-automatic or automatic means. Since the focused acoustic pressureshockwaves 40 are produced in a liquid medium, in order to not loseenergy through reflections at the change of acoustic impedance from onemedium to another and fully take advantage of the micro-jets produced bythe collapse of cavitation bubbles, the endoscope 30 or the reusablecontaminated tubing 30 are placed into liquid bath 93 and theirlumen/lumens filled with a decontamination fluid 205 (see FIGS. 20B and21B). The liquid bath enclosure 171 of the liquid bath 93 has the properdimensions to accommodate the applicator 97 and the endoscope 30 orreusable contaminated tubing 30 that must stay submerged at all time inthe field of action of the applicator 97 and its focal volume 48 duringthe cleaning and the high-level disinfection process. Considering thesignificant length of an endoscope 30 or reusable contaminated tubing30, to not increase considerable the dimensions of the bath enclosure171, the endoscope 30 or reusable contaminated tubing 30, after passingin front of the focused acoustic pressure shockwaves 40 and through thefocal volume 48, can exit the liquid bath 93. Similarly, the endoscope30 or reusable contaminated tubing 30 should enter the liquid bath 93just before passing in front of the focused acoustic pressure shockwaves40 and through the focal volume 48. To accomplish that the endoscope 30,or reusable contaminated tubing 30 from respirators or hemodialysisunits or from any other medical devices is moving in thetubing/endoscope moving direction 92 and in front of the focusedacoustic pressure shockwaves 40. Alternatively, in other situations theapplicator 97 can be moved (instead of the medical tubing 30 such asendoscopes and other reusable medical device tubes) and sometimes boththe applicator 97 and the medical tubing 30 such as endoscopes and otherreusable medical device tubes are moving in opposite directions, usingmanually or motorized automatic means.

Although it was mentioned before that the embodiment from FIGS. 17A and17B can be used for the cleaning and decontamination of endoscopes 30 orof the reusable contaminated tubing 30, specifically in the figure theschematic representation is of an endoscope 30, which shows differentendoscope channels 170 found in an endoscope 30. Note that theapplicator/coupling membrane 44 is in close contact and deforms (“hugs”)around the surface of the endoscope 30 or reusable contaminated tubing30, which assures an efficient action of the focused acoustic pressureshockwaves 40 inside the lumen or lumens of the endoscope 30 or reusablecontaminated tubing 30. In this embodiment and the majority of theembodiments presented in the present inventions, the decontaminationsystem 90 is focused on the cleaning and decontamination of the internallumen of a reusable contaminated medical tubing 30 or of the endoscopechannels 170 and less on their external surface, which in general can bemuch easier cleaned and high-level disinfected with classic/legacymethods. However, if the cleaning and high-level disinfection is neededto be performed by shockwaves or pressure waves or ultrasound for bothexternal surface and the internal lumen or lumens of an endoscope 30 orreusable contaminated tubing 30, then there is no contact in between theapplicator/coupling membrane 44 and the external surface of theendoscope 30 or reusable contaminated tubing 30, as presented in theembodiment from FIG. 22 .

In FIGS. 17A and 17B if the semi-ellipsoidal reflector 42 is replacedwith a parabolic reflector 51 (see FIG. 5 ) that has its parabolic focalpoint (F) in the same position as the first focal point (F₁) of thesemi-ellipsoidal reflector 42, then the applicator 97 will producepseudo-planar pressure waves 40, similar to those from the embodimentpresented in FIG. 11 .

Although the embodiment presented in FIGS. 17A and 17B showsspecifically an electrohydraulic system that uses the spark-gap 41, theapplicators 97 can also produce focused acoustic pressure shockwaves 40or pressure waves (pseudo-planar pressure waves 40 or acoustic radialpressure waves 40) and low-frequency ultrasound waves 380 and 381 usingelectrohydraulic generators with lasers, piezoelectric generators (withpiezo crystals/piezo ceramics or piezo fibers) or electromagneticgenerators (with flat coils or cylindrical coils).

FIG. 18 shows an actual cleaning and high-level disinfection fixture 180for endoscopes 30 or reusable contaminated tubing 30 from ventilatorsand dialysis machines or from any other medical devices. The cleaningand high-level disinfection fixture 180 is using one applicator 97 thathas its applicator/coupling membrane 44 in direct contact with theendoscope 30 or reusable contaminated tubing 30. The endoscope 30 orreusable contaminated tubing 30 is moving in the tubing/endoscope movingdirection 92 through manually actuation or by usingsemi-automatic/motorized systems. As seen from FIG. 18 , thetubing/endoscope moving direction 92 allows the constant movement of theendoscope 30 or reusable contaminated tubing 30 through the focal volume48 created by focused acoustic pressure shockwaves 40 that are producedby applicator 97. However, the same cleaning and high-level disinfectionfixture 180 can also use unfocused pressure waves, acoustic planarpressure wave 374 or pseudo-planar pressure wave 40 or acoustic radialpressure wave 40 and low-frequency ultrasound waves 380 and 381, whenthe applicator 97 has different configurations, as presented in theembodiments from the inventions disclosed herein. Also, the embodimentpresented in FIG. 18 can use applicators 97 that can produce focusedacoustic pressure shockwaves 40 or pressure waves (acoustic planarpressure waves 374 or pseudo-planar pressure waves 40 or acoustic radialpressure waves 40) and low-frequency ultrasound waves 380 and 381 usingelectrohydraulic generators (with spark-gaps or lasers), piezoelectricgenerators (with piezo crystals/piezo ceramics or piezo fibers) orelectromagnetic generators (with flat coils or cylindrical coils).

The number of applicators 97 that are used during cleaning andhigh-level disinfection of endoscopes 30 or reusable contaminated tubing30 from ventilators and dialysis machines or from any other medicaldevices can vary from one applicator to two or more applicators, basedon the necessary efficiency, soiling and processing time. FIGS. 19A and19B show a manual or semi-automatic system for cleaning and disinfectionendoscopes 30 or reusable contaminated tubing 30 from ventilators anddialysis machines or from any other medical devices, which has twoconfocal and opposite applicators 97 in direct contact with theendoscope 30 or reusable contaminated tubing 30 (via theapplicator/coupling membranes 44). Due to the overlap of the two focalvolumes 48 produced by the two applicators over the endoscopes 30 orreusable contaminated tubing 30, this embodiment is capable to producemore energy for the cleaning and the high-level disinfection process.The activation of the two applicators 97 can be done simultaneously orconcomitantly, depending on the wanted outcomes of the respectiveprocess and type of endoscope 30 or reusable contaminated tubing 30. Thefocused acoustic pressure shockwaves 40 (not shown in FIGS. 19A and 19B)are generated via high voltage discharge produced in between firstelectrode 45A and the second electrode 45B (electrohydraulic principleusing spark gap high voltage discharges) in a fluid present inside thereflector cavity 43. The high voltage for the first electrode 45A andthe second electrode 45B is provided by the power supply 95 (included incontrol console/unit 96) via high voltage cable 94. The two electrodes45A and 45B are positioned in the first focal point F₁ (forming thespark-gap 41, as presented in FIG. 4 ) of the semi-ellipsoidal reflector42. During high voltage discharge a plasma bubble is generated thatexpands and collapses transforming the heat into kinetic energy in theform of acoustic pressure shockwaves that reflect on thesemi-ellipsoidal reflectors 42, producing the focused acoustic pressureshockwaves 40, which are directed through the applicator/couplingmembrane 44 towards the common focal point F₂ and overall to the focalvolumes 48 that overlap with the targeted cleaning and high-leveldisinfection region where the endoscope 30 or reusable contaminated 30is present. To be able to properly overlap the focal volumes 48 with theendoscope 30 or reusable contaminated tubing 30, the transversal (T) andlongitudinal (L) motions of the applicators 97 are performed manually bythe operator or by using semi-automatic or automatic means. Since thefocused acoustic pressure shockwaves 40 are produced in a liquid medium,in order to not lose energy through reflections at the change ofacoustic impedance from one medium to another and fully take advantageof the micro-jets produced by the collapse of cavitation bubbles, theendoscope 30 or the reusable contaminated tubing 30 are placed intoliquid bath 93 (not specifically shown in FIGS. 19A and 19B for clarity)and their lumen/lumens filled with a decontamination fluid 205 (seeFIGS. 20B and 21B).

FIGS. 19A and 19B show the two applicators 97 positioned at 180 degreesapart (opposite), but they can be also at 90 degrees apart. In case thatmore than two applicators 97 are used, they can be positioned at anyangular position around the endoscope 30 or reusable contaminated tubing30. If three applicators 97 are used, they can be positioned at 120degrees equally apart, or if four applicators 97 are used, they can bepositioned at 90 degrees equally apart and so on. In other situations,the applicators 97 do not necessarily need to be positioned equallyapart. For example, if four applicators 97 are used, the top two of themcan be positioned at 40 degrees apart and the bottom two at 60 degreesapart, which means that the angle in between a top applicator and abottom applicator will be 130 degrees. In the ultimate solution, themultiple applicators 97 can be moved automatically using a motorizedfixture in any position desired by the operator or by an automaticsystem, based on the analysis of the endoscope 30 or reusablecontaminated tubing 30 surface and configuration that is monitored by anautomated visual system. This approach can be also applied for valves orother intricate parts or devices that require decontamination, and theapplicators 97 need to cover all the “nooks and crannies” of suchspecial parts or components or medical devices.

In FIGS. 19A and 19B if the two semi-ellipsoidal reflectors 42 arereplaced with two parabolic reflectors 51 (see FIG. 5 ) that have theirparabolic focal point (F) in the same position as the first focal point(F₁) of the two semi-ellipsoidal reflectors 42, then the applicators 97will produce pseudo-planar pressure waves 40, similar to those from theembodiment presented in FIG. 11 . Conversely, one of the applicators 97can have the semi-ellipsoidal reflector 42 and the second one can havethe parabolic reflector 51, which will produce in the cleaning anddecontamination area/volume a combination of focused acoustic pressureshockwaves 40 and pseudo-planar pressure waves 40.

Although it was mentioned before that the embodiment from FIGS. 19A and19B can be used for the cleaning and decontamination of endoscopes 30 orof the reusable contaminated tubing 30, specifically in the figures theschematic representation is of an endoscope 30, which shows differentendoscope channels 170 found in an endoscope 30.

To assure the complete cleaning and decontamination on the full lengthof medical devices such as endoscopes 30, or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices, either the contaminated device/part needs to moveor alternatively the applicators 97 move and sometimes both, usingmanually or motorized automatic means. In FIGS. 19A and 19B, theendoscope 30, or reusable contaminated tubing 30 from respirators orhemodialysis units or from any other medical devices is moving in thetubing/endoscope moving direction 92 through the common focal volume 48.

Although the embodiment presented in FIGS. 19A and 19B showsspecifically an electrohydraulic system that uses the spark-gaps 41, theapplicators 97 can also produce focused acoustic pressure shockwaves 40or pressure waves (pseudo-planar pressure waves 40 or acoustic radialpressure waves 40) and low-frequency ultrasound waves 380 and 381 usingelectrohydraulic generators with lasers, piezoelectric generators (withpiezo crystals/piezo ceramics or piezo fibers) or electromagneticgenerators (with flat coils or cylindrical coils).

FIGS. 20A and 20B present the embodiment of multi-applicatordecontamination system 200 that uses applicators 201 for cleaning anddecontamination on the full length of medical devices such as endoscopes30. The increased number of applicators 201 is done to produce higherefficiency of cleaning and decontamination, since the medical tubing(endoscope) 30 passes in front of three consecutive applicators 201,which expedites the whole process. The three applicators 201 areinstalled into the applicators' fixture 202, which allows thesimultaneous movement and positioning of the applicators 201 using thetransversal (T) and longitudinal (L) motions. By using highlyunidirectional downward focused acoustic pressure shockwaves 40, thedislodging and elimination of the contamination layer/biofilm 204 fromthe inside of the endoscope channels 170 is produced. To have maximumeffects for cleaning and decontamination with focused acoustic pressureshockwaves 40 of the endoscope channels 170, a decontamination fluid 205is present or continuously circulated inside and through the endoscopechannels 170. The applicators 201 use a special applicator/couplinginverted conical membrane 203 that is in close contact and deforms(“hugs”) around the surface of the medical tubing (endoscope) 30, whichassures an efficient action of the focused acoustic pressure shockwaves40 inside the lumen or lumens of the endoscope 30 (endoscope channels170). In this embodiment and the majority of the embodiments presentedin the present inventions, the multi-applicator decontamination system200 is focused on the cleaning and decontamination of the internal lumenof the endoscope channels 170 and less on the endoscope 30 externalsurface, which in general can be much easier cleaned and high-leveldisinfected with classic/legacy known methods.

The multi-applicator decontamination system 200 is using the focusedacoustic pressure shockwaves 40 that are generated via high voltagedischarge produced in between first electrode 45A and the secondelectrode 45B (electrohydraulic principle using spark gap high voltagedischarges) in a fluid present inside each reflector cavity 43. For eachapplicator 201, the high voltage for the first electrode 45A and thesecond electrode 45B is provided by the power supply 95 (included incontrol console/unit 96) via high voltage cable 94. The two electrodes45A and 45B are positioned in the first focal point F₁ (forming thespark-gap 41, as presented in FIG. 4 ) of the semi-ellipsoidalreflectors 42. During high voltage discharge a plasma bubble isgenerated that expands and collapses transforming the heat into kineticenergy in the form of acoustic pressure shockwaves that reflect on thesemi-ellipsoidal reflector 42, producing the focused acoustic pressureshockwaves 40, which are directed through the applicator/couplinginverted conical membrane 203 towards the focal point F₂ of theellipsoidal geometry and overall to the focal volumes 48 that overlapwith the targeted cleaning and high-level disinfection region where theendoscope 30 is present. To be able to properly overlap the focalvolumes 48 with the endoscope 30, the transversal (T) and longitudinal(L) motions of the applicators 201 and applicators' fixture 202 areperformed manually by the operator or by using semi-automatic orautomatic means. Since the focused acoustic pressure shockwaves 40 areproduced in a liquid medium, in order to not lose energy throughreflections at the change of acoustic impedance from one medium toanother and fully take advantage of the micro-jets produced by thecollapse of cavitation bubbles, the medical tubing (endoscope) 30 isplaced into liquid bath 93 and endoscope channels 170 are filled with adecontamination fluid 205. The liquid bath enclosure 171 of the liquidbath 93 has the proper dimensions to accommodate the applicators 201 andthe medical tubing (endoscope) 30 that must stay submerged at all timein the field of action of the applicators 201 and their focal volumes 48(not shown in FIGS. 20A and 20B) during the cleaning and the high-leveldisinfection process. Considering the significant length of an endoscope30, to not increase considerable the dimensions of the bath enclosure171, the medical tubing (endoscope) 30 after passing in front of thefocused acoustic pressure shockwaves 40 and through the focal volumes48, can exit the liquid bath 93. Similarly, the medical tubing(endoscope) 30 should enter the liquid bath 93 just before passing infront of the focused acoustic pressure shockwaves 40 and through thefocal volumes 48. To accomplish that the medical tubing (endoscope) 30is moving in the tubing/endoscope moving direction 92 and in front ofthe focused acoustic pressure shockwaves 40.

Although the embodiment presented in FIGS. 20A and 20B showsspecifically an electrohydraulic system that uses the spark-gaps 41, theapplicators 201 can produce besides focused acoustic pressure shockwaves40 also pressure waves (pseudo-planar pressure wave 40 or acousticradial pressure wave 40) and low-frequency ultrasound waves 380 and 381using electrohydraulic generators with lasers, piezoelectric generators(with piezo crystals/piezo ceramics or piezo fibers) or electromagneticgenerators (with flat coils or cylindrical coils).

The embodiment presented in FIGS. 21A and 21B shows multi-applicatordecontamination system 200 that uses applicators 201 for cleaning anddecontamination on the full length of reusable contaminated tubing 30from respirators or hemodialysis units or from any other medicaldevices. The increased number of applicators 201 is done to producehigher efficiency of cleaning and decontamination, since the reusablecontaminated tubing 30 passes in front of three consecutive applicators201, which expedites the whole process. The three applicators 201 areinstalled into the applicators' fixture 202, which allows thesimultaneous movement and positioning of the applicators 201 using thetransversal (T) and longitudinal (L) motions. By using highlyunidirectional downward focused acoustic pressure shockwaves 40, thedislodging and elimination of the contamination layer/biofilm 204 fromthe inside of the reusable contaminated tubing 30 is produced. To havemaximum effects for cleaning and decontamination with focused acousticpressure shockwaves 40 of the reusable contaminated tubing 30, adecontamination fluid 205 is present or continuously circulated throughits internal lumen/lumens. The applicators 201 use a specialmulti-applicator coupling membrane 210 that is a common membrane for allthree applicators 201 and it is in close contact and deforms (“hugs”)around the corrugated surface of the reusable contaminated tubing 30,which assures an efficient action of the focused acoustic pressureshockwaves 40 inside the lumen or lumens of the reusable contaminatedtubing 30. In this embodiment, the multi-applicator decontaminationsystem 200 is focused on the cleaning and decontamination of theinternal lumen or lumens of the reusable contaminated tubing 30 and lesson its external surface, which in general can be much easier cleaned andhigh-level disinfected with classic/legacy known methods.

The multi-applicator decontamination system 200 is using the focusedacoustic pressure shockwaves 40 that are generated via high voltagedischarge produced in between first electrode 45A and the secondelectrode 45B (electrohydraulic principle using spark gap high voltagedischarges) in a fluid present inside each reflector cavity 43. For eachapplicator 201, the high voltage for the first electrode 45A and thesecond electrode 45B is provided by the power supply 95 (included incontrol console/unit 96) via high voltage cable 94. The two electrodes45A and 45B are positioned in the first focal point F₁ (forming thespark-gap 41, as presented in FIG. 4 ) of the semi-ellipsoidalreflectors 42. During high voltage discharge a plasma bubble isgenerated that expands and collapses transforming the heat into kineticenergy in the form of acoustic pressure shockwaves that reflect on thesemi-ellipsoidal reflector 42, producing the focused acoustic pressureshockwaves 40, which are directed through the special multi-applicatorcoupling membrane 210 towards the focal point F₂ of the ellipsoidalgeometry and overall to the focal volumes 48 that overlap with thetargeted cleaning and high-level disinfection region where the endoscope30 is present. To be able to properly overlap the focal volume 48 withthe reusable contaminated tubing 30, the transversal (T) andlongitudinal (L) motions of the applicators 201 and applicators' fixture202 are performed manually by the operator or by using semi-automatic orautomatic means. Since the focused acoustic pressure shockwaves 40 areproduced in a liquid medium, in order to not lose energy throughreflections at the change of acoustic impedance from one medium toanother and fully take advantage of the micro-jets produced by thecollapse of cavitation bubbles, the reusable contaminated tubing 30 isplaced into liquid bath 93 and its lumen or lumens are filled with adecontamination fluid 205. The liquid bath enclosure 171 of the liquidbath 93 has the proper dimensions to accommodate the applicators 201 andthe reusable contaminated tubing 30 that must stay submerged at all timein the field of action of the applicators 201 and their focal volumes 48(not shown in FIGS. 21A and 21B) during the cleaning and the high-leveldisinfection process. Considering the significant length of a reusablecontaminated tubing 30, to not increase considerable the dimensions ofthe bath enclosure 171, the reusable contaminated tubing 30 afterpassing in front of the focused acoustic pressure shockwaves 40 andthrough the focal volumes 48, can exit the liquid bath 93. Similarly,the reusable contaminated tubing 30 should enter the liquid bath 93 justbefore passing in front of the focused acoustic pressure shockwaves 40and through the focal volumes 48. To accomplish that the reusablecontaminated tubing 30 is moving in the tubing/endoscope movingdirection 92 and in front of the focused acoustic pressure shockwaves40.

Although the embodiment presented in FIGS. 21A and 21B showsspecifically an electrohydraulic system that uses the spark-gaps 41, theapplicators 201 can also produce focused acoustic pressure shockwaves40, or pressure waves (pseudo-planar pressure wave 40 or acoustic radialpressure wave 40), and low-frequency ultrasound waves 380 and 381 usingelectrohydraulic generators with lasers, piezoelectric generators (withpiezo crystals/piezo ceramics or piezo fibers) or electromagneticgenerators (with flat coils or cylindrical coils).

If the cleaning and decontamination of both the external surface and theinternal lumen or lumens of a reusable contaminated tubing 30 must beaccomplished at the same time, then the embodiment from FIG. 22 is used.This approach comes in handy when the external surface of the reusablecontaminated tubing 30 is intricate or have texture, as it is the caseswith the corrugated reusable contaminated tubing 30 from FIG. 22 . Notethat the multi-applicator decontamination system 200 has the applicators201 not in contact with the external surface of the reusablecontaminated tubing 30, which allows the action of the compressiveforces and the formation of cavitation bubbles both inside and outsidethe reusable contaminated tubing 30. In this way the cleaning anddecontamination can be accomplished successful on both external andinternal surfaces of the reusable contaminated tubing 30. As seen inFIG. 22 , the applicators 201 can be independent (allows individualflexibility in positioning them around and/or along the reusablecontaminated tubing 30) or can be part of an applicators' fixture 202,as presented before in FIGS. 20A-21B. The comments presented before forFIGS. 19A and 19B, related to the positioning around the reusablecontaminated tubing 30, and comments from FIGS. 20A-21B, related toconstruction, positioning along the reusable contaminated tubing 30 andfunctionality of the multi-applicator decontamination system 200, applyalso to the embodiment from FIG. 22 .

Although the embodiments from FIGS. 20A-22 shown only three applicators201, depending on type of device that needs cleaning anddecontamination, more than three applicators 201 can be used, which canbe deployed around or along the length of an endoscope 30 or a reusablecontaminated tubing 30. In this situation, the multi-applicatordecontamination system 200 will have applicators 201 capable of beingpositioned or moved around and along the endoscopes 30 or a reusablecontaminated tubing 30 using a manual approach or an automatic fixturethat uses multiple step-motors. The positioning of the applicators 201around and along the endoscopes 30 or a reusable contaminated tubing 30can follow a certain algorithm dictated by a dedicated software program.

Although the embodiment presented in FIG. 22 shows specifically anelectrohydraulic system that uses the spark-gaps 41, the applicators 201can also produce focused acoustic pressure shockwaves 40, or pressurewaves (pseudo-planar pressure wave 40 or acoustic radial pressure wave40), and low-frequency ultrasound waves 380 and 381 usingelectrohydraulic generators with lasers, piezoelectric generators (withpiezo crystals/piezo ceramics or piezo fibers) or electromagneticgenerators (with flat coils or cylindrical coils).

As seen in the embodiment from FIG. 23 , the endoscopes 30 or thereusable contaminated tubing/tubes 30 have a large diameter that doesnot allow the full diametric coverage by the focal volumes 48 producedby applicators 201 and this is why an alternating placement is needed.For the proper dislodging and elimination of the contaminationlayer/biofilm 204 from the inside of the endoscope channels 170 (notspecifically shown in FIG. 23 ) or inner lumen or lumens of a reusablecontaminated tubing 30, the endoscope 30 or the reusable contaminatedtubing 30 is moving in the tubing/endoscope moving direction 92 and infront of the focused acoustic pressure shockwaves 40 (not shown in FIG.23 for simplicity) and through the focal volumes 48. Since the focusedacoustic pressure shockwaves 40 are produced in a liquid medium, inorder to not lose energy through reflections at the change of acousticimpedance from one medium to another and fully take advantage of themicro-jets produced by the collapse of cavitation bubbles, the endoscope30 or the reusable contaminated tubing 30 is placed into liquid bath 93and its lumen or lumens are filled with a decontamination fluid 205.

The total number of applicators 201 used in this embodiment is six andthey are positioned alternatively on the length of the endoscope 30 orof the reusable contaminated tubing 30 from respirators, hemodialysisunits and any other medical devices. Of course, the number ofapplicators 201 can be lower or higher than six, depending on thespecifics of each cleaning and decontamination cycle. In FIG. 23 , theapplicators 201 are placed alternately on the length of the endoscope 30or the reusable contaminated tubing 30 and subsequent applicators 201are at 180 degrees around the endoscope 30 or the reusable contaminatedtubing 30. Alternatively, the subsequent applicators 201 can bepositioned at 45, 60, 90 or 120 degrees around the endoscope 30 or thereusable contaminated tubing 30. The ultimate solution is where amotorized system can move automatically the applicators 201 in anyposition desired by the operator or by an automatic system. Regardlessof configuration, the most important thing is to cover entirely thewhole circumference of the endoscope 30 or the reusable contaminatedtubing 30 and along its full length. Any above-mentioned configurationsthat use the multiple applicators 201 approach can be also applied forvalves or other intricate parts or devices that require decontamination,and the applicators 201 need to cover all the “nooks and crannies” ofsuch special parts or components or medical devices.

For FIG. 23 all types of generation principles apply for creatingfocused acoustic pressure shockwaves 40 such as electrohydraulic withspark-gaps or lasers, piezoelectric with piezo-crystals/piezo-ceramicsor piezo fibers, or electromagnetic with cylindrical coils or flatcoils. The same generation principles can also be applied to producepressure waves (pseudo-planar pressure wave 40 or acoustic radialpressure wave 40) and low-frequency ultrasound waves 380 and 381, whichare also working to produce the cleaning and decontamination ofendoscopes 30 or of the reusable contaminated tubing/tubes 30 with theembodiment from FIG. 23 .

Due to increased number of applicators 201 for the embodiments presentedin FIGS. 19-23 , the foot imprint and height of the liquid bath 93 andassociated bath enclosure 171 is increased when compared to theembodiments that use only one applicator 97, as presented in FIGS. 9-18. However, the dimensional increase for the liquid bath 93 andassociated bath enclosure 171 and operational complexity, can bejustified by the increase in efficiency of cleaning and decontaminationthat is one of the paramount factors that is pursued by a largeoperation, which can process a large number of endoscopes 30 or of thereusable contaminated tubing/tubes 30 from respirators, hemodialysisunits and any other medical devices. Computer control providesflexibility for the whole cleaning and decontamination system.

If reflectors with angled geometries are used for cleaning anddecontamination of endoscopes 30 or of the reusable contaminatedtubing/tubes 30 from respirators, hemodialysis units and any othermedical devices, then the embodiment presented in FIG. 24 can becreated. To create the con-focal applicators decontamination system 240,four pieces (first confocal reflector portion 241, second confocalreflector portion 242, con-focal applicator body 243, and con-focalapplicators handle 244) are assembled together to achieve the presentedreflector cavity 43 used to harbor a fluid in which focused acousticpressure shockwaves 40 (not shown in FIG. 24 for clarity) are creatingtwo different focal volumes 48A and 48B. The focal volumes (firstreflector focal volume 48A and second reflector focal volume 48B) can beconfocal and partially overlap to produce more energy for cleaning anddecontamination of the endoscopes 30 or of the reusable contaminatedtubing/tubes 30 from respirators, hemodialysis units, and any othermedical devices, as seen in FIG. 24 . Alternatively, the two focalvolumes 48A and 48B can be totally separated (without any overlap), butrather adjacent.

To be able to create the embodiment from FIG. 24 , only partialellipsoidal reflectors can be used. To maintain sufficient efficiencyand minimal interference in between them, the first confocal reflectorportion 241 and the second confocal reflector portion 242 need to berather deep than shallow. This is why the ratio of the major ellipticalsemi axis “c” and minor elliptical semi axis “b” (as seen in FIG. 7 )for these reflectors should be higher or equal with 2, which is thecharacteristic of deep ellipsoidal reflectors.

The con-focal applicators decontamination system 240 is using thefocused acoustic pressure shockwaves 40 that are generated via highvoltage discharge produced in between first electrode 45A and the secondelectrode 45B of the first confocal reflector portion 241 and the thirdelectrode 45A′ and the fourth electrode 45B′ of the second confocalreflector portion 242 (electrohydraulic principle using spark gap highvoltage discharges) in a fluid present inside each reflector cavity 43.For applicators 241 and 242, the high voltage for the electrodes 45A,45B, 45A′, and 45B′ is provided by the power supply 95 (included incontrol console/unit 96) via high voltage cable 94. The two electrodes45A and 45B are positioned in the first focal point F₁ of the firstconfocal reflector portion 241 and the third and fourth electrodes 45A′and 45B′ are positioned in the first focal point F₁ of the secondconfocal reflector portion 242 (forming the spark-gaps 41, as presentedin FIG. 4 ). During high voltage discharge a plasma bubble is generatedthat expands and collapses transforming the heat into kinetic energy inthe form of acoustic pressure shockwaves that reflect on the firstconfocal reflector portion 241 and the second confocal reflector portion242, producing the focused acoustic pressure shockwaves 40, which aredirected through the applicator/coupling membrane 44 towards the focalpoint F₂, that is common for the two reflectors. The two focal volumes48A and 48B overlap with the targeted cleaning and high-leveldisinfection region where the endoscope 30 and the reusable contaminatedtubing 30 is present. To be able to properly overlap the focal volumes48A and 48B with endoscope 30 and the reusable contaminated tubing 30,the transversal (T) and longitudinal (L) motions of the con-focalapplicators decontamination system 240 are performed manually by theoperator or by using semi-automatic or automatic means. Since thefocused acoustic pressure shockwaves 40 are produced in a liquid medium,in order to not lose energy through reflections at the change ofacoustic impedance from one medium to another and fully take advantageof the micro-jets produced by the collapse of cavitation bubbles, theendoscope 30 and the reusable contaminated tubing 30 is placed intoliquid bath 93 and its lumen or lumens are filled with a decontaminationfluid 205 (see FIGS. 20B, 21B, 22 and 23 ). The liquid bath 93 has theproper dimensions to accommodate the con-focal applicatorsdecontamination system 240 and the endoscope 30 and the reusablecontaminated tubing 30 that must stay submerged at all time in the fieldof action of the con-focal applicators decontamination system 240 andits focal volumes 48A and 48B during the cleaning and the high-leveldisinfection process. Considering the significant length of an endoscope30 and of a reusable contaminated tubing 30, to not increaseconsiderable the dimensions of the bath enclosure 171, the endoscope 30and the reusable contaminated tubing 30 after passing in front of thefocused acoustic pressure shockwaves 40 and through the focal volumes48A and 48B, can exit the liquid bath 93. Similarly, the endoscope 30and the reusable contaminated tubing 30 should enter the liquid bath 93just before passing in front of the focused acoustic pressure shockwaves40 and through the focal volumes 48A and 48B. To accomplish that theendoscope 30 and the reusable contaminated tubing 30 is moving in thetubing/endoscope moving direction 92 and in front of the focusedacoustic pressure shockwaves 40.

In certain situations, two or more con-focal applicators decontaminationsystems 240 can be used for cleaning and decontamination of theendoscopes 30 or of the reusable contaminated tubing 30 fromrespirators, hemodialysis units and any other medical devices. Thepositioning of the multiple con-focal applicators decontaminationsystems 240 can be sequential along the length or angular around theendoscope 30 and the reusable contaminated tubing 30, with the samevariations as mentioned for FIGS. 19A, 19B, and 23 .

Although the embodiment presented in FIG. 24 shows specifically anelectrohydraulic system that uses the spark-gaps 41, the applicators 241and 242 can also produce focused acoustic pressure shockwaves 40 orpressure waves (pseudo-planar pressure waves 40 or acoustic radialpressure waves 40) and low-frequency ultrasound waves 380 and 381 usingelectrohydraulic generators with lasers, piezoelectric generators (withpiezo crystals/piezo ceramics or piezo fibers) or electromagneticgenerators (with flat coils or cylindrical coils).

The embodiment presented in FIGS. 25A and 25B, is using adecontamination system with elongated applicator 250 that incorporatesthe special elongated reflector 251. The decontamination system withelongated applicator 250 can increase efficiency of cleaning anddecontamination of the endoscopes 30 and of the reusable contaminatedtubing 30 from respirators, hemodialysis units, and any other medicaldevices, by triggering/producing focused acoustic pressure shockwaves 40in multiple F (spark-gaps 41) of the special elongated reflector 251.Based on the needs of the treatment, the high-voltage discharge at thespark-gaps 41 level can be done in the same time or sequential using ashockwave generator or control console/unit 96. Due to thesophistication necessary for the selective activation of the spark-gaps41, the electric power is provided by the power supply 95 via the highvoltage cable 94 and the activation commands are provided by the controlconsole 96. The cross section of the reflecting surface 257 of thespecial elongated applicator 251 can be an elliptic cross-section 252(as presented in FIG. 25A) or can be a parabola, a circle or anycombination of these geometries, when besides focused acoustic pressureshockwaves 40 also pressure waves as pseudo-planar pressure wave 40 oracoustic radial pressure wave 40, or unfocused pressure waves aregenerated. The actuation/control of the decontamination system withelongated applicator 250 can be done using the actuation button 255 (aspresented in FIG. 25B). The reflecting surface 257 can be also createdusing piezoelectric elements as piezo crystal s/piezo ceramics, thinfilms or piezo fibers. The reflector aperture 254 of the elongatedapplicator 251 is narrow and accommodates the narrow coupling membrane253, creating the reflector cavity 43. The dimensions of the reflectoraperture 254 and of the narrow coupling membrane 253 that sits on top ofthe reflector aperture 254, it is comparable or larger than thediametric dimension of the endoscopes 30 or of the reusable contaminatedtubing 30, to assure a complete and efficient cleaning anddecontamination.

The decontamination system with elongated applicator 250 is using thefocused acoustic pressure shockwaves 40 (not shown in FIG. 25A or 25Bfor simplicity) that are generated via high voltage discharge producedin between electrodes that form the spark-gaps 41 (electrohydraulicprinciple using spark gap high voltage discharges) in a fluid presentinside the cavity 43 of the special elongated reflector 251. For thespecial elongated reflector 251, the high voltage for the electrodes isprovided by the power supply 95 (included in control console/unit 96)via high voltage cable 94. During high voltage discharge a plasma bubbleis generated that expands and collapses transforming the heat intokinetic energy in the form of acoustic pressure shockwaves that reflecton the special elongated reflector 251, producing the focused acousticpressure shockwaves 40, which are directed through the narrow couplingmembrane 253 towards the focal points F₂. The multiple focal volumes 48overlap with the targeted cleaning and high-level disinfection regionwhere the endoscope 30 and the reusable contaminated medical tubing 30is present. To be able to properly overlap the focal volumes 48 withendoscope 30 and the reusable contaminated tubing 30, the transversal(T) and longitudinal (L) motions of the decontamination system withelongated applicator 250 are performed manually by the operator or byusing semi-automatic or automatic means. Since the focused acousticpressure shockwaves 40 are produced in a liquid medium, in order to notlose energy through reflections at the change of acoustic impedance fromone medium to another and fully take advantage of the micro-jetsproduced by the collapse of cavitation bubbles, the endoscope 30 and thereusable contaminated tubing 30 is placed into liquid bath 93 and itslumen or lumens are filled with a decontamination fluid 205 (see FIGS.20B, 21B, 22 and 23 ). The liquid bath 93 has the proper dimensions toaccommodate the decontamination system with elongated applicator 250 andthe endoscope 30 and the reusable contaminated tubing 30 that must staysubmerged at all time in the field of action of the decontaminationsystem with elongated applicator 250 and its focal volumes 48 during thecleaning and the high-level disinfection process. Considering thesignificant length of an endoscope 30 and of a reusable contaminatedtubing 30, to not increase considerable the dimensions of the liquidbath 93, the endoscope 30 and the reusable contaminated tubing 30 afterpassing in front of the focused acoustic pressure shockwaves 40 andthrough the focal volumes 48, can exit the liquid bath 93. Similarly,the endoscope 30 and the reusable contaminated tubing 30 should enterthe liquid bath 93 just before passing in front of the focused acousticpressure shockwaves 40 and through the focal volumes 48. To accomplishthat the endoscope 30 and the reusable contaminated tubing 30 is movingin the tubing/endoscope moving direction 92 and in front of the focusedacoustic pressure shockwaves 40.

In certain situations, two or more decontamination systems withelongated applicator 250 can be used for cleaning and decontamination ofthe endoscopes 30 or of the reusable contaminated tubing 30 fromrespirators, hemodialysis units and any other medical devices. Thepositioning of the multiple decontamination systems with elongatedapplicator 250 can be sequential along the length or angular around theendoscope 30 and the reusable contaminated tubing 30, with the samevariations as mentioned for FIGS. 19A, 19B, 23, and 24 .

To assure the complete cleaning and decontamination on the full lengthof medical devices such as endoscopes 30, or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices, either the contaminated device/part needs to moveor alternatively the decontamination system with elongated applicator250 moves and sometimes both, using manually or motorized automaticmeans. In FIG. 25B the endoscope 30, or reusable contaminated tubing 30from respirators or hemodialysis units or from any other medical devicesis moving in the tubing/endoscope moving direction 92 and in front ofthe focused acoustic pressure shockwaves 40.

FIG. 26 shows a decontamination system with pipe reflectors 260 that isusing pipe reflectors 261. A pipe reflector 261 is made of a hypotube(thin metal tube) shaped in the form of a pipe with a cross-section 263(such as elliptical, parabolic or combination semi-spherical andconical), which are used to focus the focused acoustic pressureshockwaves 40, or direct the pseudo-planar pressure waves 40, oracoustic radial pressure waves 40, or unfocused pressure waves 40generated by the high voltage discharge in the discharge points 262. Theelliptical cross-section 263 for the pipe reflector 261 can focus awayfocused acoustic pressure shockwaves 40 generated by the dischargepoints 262 towards the focal volumes 48 (not shown in FIG. 26 ) thatintersect and overlap with the endoscopes 30 or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices. If the endoscopes 30 or the reusable contaminatedtubing 30 are placed before the focal volumes 48, then they are subjectto the unfocused pressure waves. When a parabolic cross-section 263 isused for the pipe reflector 261, the discharge points 262 represent theparabolic focal points (seen before in FIG. 5 ) and pseudo-planarpressure waves 40 will be generated outside the pipe reflector 261 andcreate the pseudo-planar waves pressure field 55 (see FIG. 5 ) that mustoverlap with the endoscopes 30 or of the reusable contaminated tubing 30from respirators, hemodialysis units and any other medical devices. Whena combination semi-spherical and conical cross section 263 is used forthe pipe reflector 261, the discharge points 262 represent the spherecentral point (seen before in FIG. 6 ) and acoustic radial pressurewaves 40 will be generated outside the pipe reflector 261 and create theradial waves pressure field 63 (see FIG. 6 ) that must overlap with theendoscopes 30 or of the reusable contaminated tubing 30 fromrespirators, hemodialysis units and any other medical devices. Theactual example depicted in FIG. 26 is an endoscope, and thus theendoscope channels 170 are shown that are usually filled with adecontamination fluid 205 (not specifically shown in FIG. 26 ) duringthe cleaning and decontamination process.

The discharge points 262 of the pipe reflector 261 can be all activatedsimultaneously or subsequently, and in other cases, only selectivedischarge points or individual points can be activated to match thespecific requirements of the cleaning and decontamination process of theendoscopes 30 or of the reusable contaminated tubing 30 fromrespirators, hemodialysis units and any other medical devices. Due tothe sophistication necessary for the selective activation of thedischarge points 262, the electric power is provided by the power supply95 via the high voltage cable 94 and the activation commands areprovided by the control console 96 (elements not specifically shown inFIG. 26 ).

To assure the complete cleaning and decontamination on the full lengthof medical devices such as endoscopes 30, or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices, either the contaminated device/part needs to moveor alternatively the decontamination system with pipe reflectors 260moves and sometimes both, using manually or motorized automatic means.In FIG. 26 the endoscope 30, or reusable contaminated tubing 30 fromrespirators or hemodialysis units or from any other medical devices ismoving in the tubing/endoscope moving direction 92 and in front of thefocused acoustic pressure shockwaves 40, or direct the pseudo-planarpressure waves 40, or acoustic radial pressure waves 40, or unfocusedpressure waves.

Although the embodiment presented in FIG. 26 shows specifically anelectrohydraulic system that uses the spark-gaps 41, the decontaminationsystem with pipe reflectors 260 can also produce focused acousticpressure shockwaves 40 or pressure waves (pseudo-planar pressure waves40 or acoustic radial pressure waves 40) and low-frequency ultrasoundwaves 380 and 381 using electrohydraulic generators with lasers,piezoelectric generators (with piezo crystals/piezo ceramics or piezofibers) or electromagnetic generators (with flat coils or cylindricalcoils).

The embodiment from FIG. 27 shows a cross-section of amanual/semi-automatic decontamination system 270 using a singleapplicator 97 for cleaning and decontamination of endoscopes 30 or ofthe reusable contaminated tubing 30 from respirators, hemodialysis unitsand any other medical devices. As mentioned before for FIGS. 20A-21B and24-25B, to not increase considerable the dimensions of the liquid bath93 and associated liquid bath enclosure 171, the endoscope 30 and thereusable contaminated tubing 30 can enter and exit the liquid bath 93immediately before and after passing in front of the focused acousticpressure shockwaves 40 or pseudo-planar pressure waves 40 or acousticradial pressure waves 40 or unfocused pressure waves. To accomplish thatthe endoscope 30 and the reusable contaminated tubing 30 is moving inthe tubing/endoscope moving direction 92 using the guiding semi-channelfixture 271. In the design of the manual/semi-automatic decontaminationsystem 270, the guiding semi-channel fixture 271 is completed integrated(one part) with the bath enclosure 171. The applicator 97 is positionedin a fixed position using the applicator supporting fixture 272. Toaccommodate different dimensions of the endoscopes 30 or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices, the vertical positioning of the applicator 97 canbe adjusted via the shims 274 that are placed beneath the applicatordepth adjusting part 273, which are practically moving the wholeapplicator supporting fixture 272 up and down.

To assure the complete cleaning and decontamination on the full lengthof medical devices such as endoscopes 30, or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices, either the contaminated device/part needs to moveor alternatively the applicator 97 moves and sometimes both, usingmanually or motorized automatic means. In FIG. 27 the endoscope 30 orreusable contaminated tubing 30 from respirators or hemodialysis unitsor from any other medical devices is moving in the tubing/endoscopemoving direction 92 and in front of the focused acoustic pressureshockwaves 40 or pseudo-planar pressure waves 40 or acoustic radialpressure waves 40 or unfocused pressure waves. The applicator 97 is indirect contact with the endoscope 30 or reusable contaminated tubing 30(via the applicator/coupling membranes 44), which assures an efficientaction on the lumen or lumens of the endoscope 30 or reusablecontaminated tubing 30. In this embodiment presented in FIG. 27 , themanual/semi-automatic decontamination system 270 is focused on thecleaning and decontamination of the internal lumen or lumens of thereusable contaminated medical tubing 30 and less on its externalsurface, which in general can be much easier cleaned and high-leveldisinfected with classic/legacy known methods.

In FIG. 27 , the manual/semi-automatic decontamination system 270 isusing the focused acoustic pressure shockwaves 40 or pseudo-planarpressure waves 40 or acoustic radial pressure waves 40 or unfocusedpressure waves that are generated via high voltage discharge produced inbetween first electrode 45A and the second electrode 45B(electrohydraulic principle using spark-gap high voltage discharges) ina fluid present inside the reflector cavity 43. The high voltage for thefirst electrode 45A and the second electrode 45B is provided by thepower supply 95 (included in control console/unit 96) via high voltagecable 94. The two electrodes 45A and 45B are positioned in the firstfocal point F₁ (focal point 47 where the spark-gap 41 is positioned, aspresented in FIG. 4 ) of the semi-ellipsoidal reflector 42 (forproducing focused acoustic pressure shockwaves 40 or unfocused pressurewaves) or in the parabolic focal point (see FIG. 5 ) of the parabolicreflector 51 (for producing pseudo-planar pressure waves 40) or thecentral sphere point (see FIG. 6 ) of the combination semi-spherical andconical reflector 61 (for producing acoustic radial pressure waves 40).During high voltage discharge a plasma bubble is generated that expandsand collapses transforming the heat into kinetic energy in the form ofshockwaves or pressure waves that reflect on the semi-ellipsoidalreflector 42, or on the parabolic reflector 51, or on the combinationsemi-spherical and conical reflector 61 producing focused acousticpressure shockwaves 40, or unfocused pressure waves, or pseudo-planarpressure waves 40, or acoustic radial pressure waves 40, which aredirected through the applicator/coupling membrane 44 towards thetargeted cleaning and high-level disinfection region where the endoscope30 or the reusable contaminated tubing 30 is present. To be able toproperly overlap the focal volume 48 (see FIG. 4 ) or the pseudo-planarwaves pressure field 55 (see FIG. 5 ) or the radial waves pressure field63 (see FIG. 6 ) with the endoscope 30 or the reusable contaminatedtubing 30, the applicator supporting fixture 272 and the shims 274 areused. Since the focused acoustic pressure shockwaves 40, orpseudo-planar pressure waves 40, or acoustic radial pressure waves 40are produced in a liquid medium, in order to not lose energy throughreflections at the change of acoustic impedance from one medium toanother and fully take advantage of the micro-jets produced by thecollapse of cavitation bubbles, the endoscope 30 or the reusablecontaminated tubing 30 is placed into liquid bath 93 of the liquid bathenclosure 171 and its lumen or lumens are filled with a decontaminationfluid 205 (see FIGS. 20B, 21B, 22 and 23 ).

Although the embodiment presented in FIG. 27 shows specifically anelectrohydraulic system that uses the spark-gap 41, the applicator 97can also produce focused acoustic pressure shockwaves 40 or pressurewaves (pseudo-planar pressure wave 40 or acoustic radial pressure wave40 or unfocused pressure waves) and low-frequency ultrasound waves 380and 381 using electrohydraulic generators with lasers, piezoelectricgenerators (with piezo crystals/piezo ceramics or piezo fibers) orelectromagnetic generators (with flat coils or cylindrical coils).

FIGS. 28A, 28B, and 28C show multiple three-dimensional views of themanual/semi-automatic decontamination system 270 that was presented indetail and its specific functioning described before in FIG. 27 . InFIGS. 28A, 28B, and 28C all the elements and their numerical depictionare the same as those from FIG. 27 .

To see better in three-dimensional fashion some of details andcomponents of the manual/semi-automatic decontamination system 270, inFIGS. 29A and 29B a blow-out representation of the embodiment from FIGS.27, 28A, 28B, and 28C is presented. Besides the applicator 97, guidingsemi-channel fixture 271 that is completely integrated (one part) withthe bath enclosure 171, applicator supporting fixture 272, applicatordepth adjusting part 273, and the shims 274, there are new elementsvisible as the visualization window 290, the visualization windowplexiglass 291, and the liquid level 292 in the liquid bath 93 of theliquid bath enclosure 171, the tabs 293 of the applicator supportingfixture 272, and the corresponding tab windows 294 for the applicatordepth adjusting part 273 and the shims 274. The role of thevisualization window 290 and its visualization window plexiglass 230 isto create for the user a window to allow the observation of the properfunctioning of the manual/semi-automatic decontamination system 270,especially in the cleaning and decontamination area where a constantcontact must be accomplished at all times in between theapplicator/coupling membrane 44 of the applicator 97 and the endoscope30 or the reusable contaminated tubing 30. The continuous observation ofthe cleaning and decontamination process can be done by a visualizationsystem (not shown in FIGS. 27-29B) that has an appropriate camera anddata analysis software. As the matter fact, FIG. 18 represents asnapshot captured by such visualization system during the cleaning anddecontamination using the manual/semi-automatic decontamination system270.

Another advantage of a blow-out view (as presented in FIGS. 29A and 29B)is that it can also show the way the manual/semi-automaticdecontamination system 270 can be assembled. Thus, the applicatorsupporting fixture 272 is first dropped and assembled into the bathenclosure 171 that has integrated in it the guiding semi-channel fixture271. Then the endoscope 30 or the reusable contaminated tubing 30 is setinto the guiding semi-channel fixture 271. Afterwards, the applicator 97is dropped inside the applicator supporting fixture 272 and correctlypositioned relatively to the guiding semi-channel fixture 271 andendoscope 30 or the reusable contaminated tubing 30 using the tabs 293of the applicator supporting fixture 272 that must enter into the tabwindows 294 for the applicator depth adjusting part 273. If theapplicator 97 needs vertical adjustment, then the necessary number ofshims 274 are assembled on the tabs 293 using their tab windows 294.Then, the applicator depth adjusting part 273 is secured in place tokeep the applicator 97 in contact with the endoscope 30 or the reusablecontaminated tubing 30, and the manual/semi-automatic decontaminationsystem 270 is filled with appropriate fluid to the liquid level 292 andalso a fluid is circulated through the endoscope 30 and the reusablecontaminated tubing 30. Finally, the endoscope 30 or the reusablecontaminated tubing 30 is connected to the motorized fixture (not shownin FIGS. 27-29B) that produces the constant moving in thetubing/endoscope moving direction 92, the applicator 97 is energized,and the visualization system activated. At this point in time thecleaning and decontamination of the endoscope 30 or the reusablecontaminated tubing 30 is in progress. At the end of the cleaning anddecontamination process, the manual/semi-automatic decontaminationsystem 270 is disassembled following the same steps but in the reversedorder.

FIG. 30 presents a full ellipsoidal reflector 300 and the way theshockwave focusing 46 is produced towards the focal point 47. Thus, if athree-dimensional reflector is created in the form of an ellipsoid, thepressure shockwaves generated in the first focal point F₁ (where thespark-gap 41 is found) will be reflected with minimal losses by the fullellipsoidal reflector 300 in the second focal point F₂, also known asfocal point 47. In this situation, the shockwave focusing 46 is donewith the whole ellipsoidal surface, which is different from thesemi-ellipsoidal reflector 42, when only half of the ellipsoid is usedand some portions of the shockwaves are not reflected towards the focalpoint 47 and they rather continue to propagate divergently away from thefocal point 47. This is why a full ellipsoidal reflector 300 had a highefficiency in focusing all shockwave fronts from all directions andcollect their energy right around the focal point 47. During shockwavefocusing 46, a focal volume 301 is created around F₂ (the focal point47), which has a spherical shape. In the focal volume 301 the maximumshockwave positive pressure 49B are found from the shockwave compressivephase 49D that produces macro effects, together with micro-jets(micro-effect) produced by the collapsing of the cavitation bubblesgenerated in the shockwave tensile phase 49F, as seen in FIG. 4 . InFIG. 30 the shockwaves are produced in a fluid by the high voltagedischarge in the spark-gap 41 that is formed by the first electrode 45Aand second electrode 45B, which represents the spark-gapelectrohydraulic way to produce shockwaves. Other ways to produceshockwaves are using the electromagnetic and piezoelectric principles.

In general, the amount of energy delivered to a targeted region by theshockwaves is directly proportional with the surface area of thereflector. As presented in FIG. 30 , in medical pressure shockwaveapplications the reflectors represent only a percentage of a fullellipsoid (in between 20 to 50% of the area). The more area is used forfocusing, the larger the focal volume 301 will be and thus the energydeposited inside the targeted area for shockwave action. This is why afull ellipsoidal reflector 300 that is using all its surface forreflection has the advantage of being more efficient in cleaning anddecontamination of endoscopes 30 or the reusable contaminated tubing 30from respirators, hemodialysis units and any other medical devices.

The embodiment from FIG. 31 shows a cross-section of a specialfull-ellipsoidal applicator 310 that can be used for the cleaning anddecontamination of endoscopes 30 or of the reusable contaminated tubing30 from respirators, hemodialysis units and any other medical devices.Thus, the effective cleaning and decontamination of endoscopes 30 or ofthe reusable contaminated tubing 30 can be accomplished by designing aspecial full-ellipsoidal applicator 310 that is made of the lower shell311 and upper shell 312, which are connected together via the shellsconnecting ring 313. The special full-ellipsoidal applicator 310 isusing deep ellipsoidal reflectors (have a large major elliptical semiaxis “c”, as defined in FIG. 7 ) to allow proper shockwave generationand be able to overlap and completely cover with the focal volume 301(presented in FIG. 30 and not specifically shown in FIG. 31 forsimplicity) the entire cross-sectional dimension of the endoscope 30 orof the reusable contaminated tubing 30 that needs cleaning anddecontamination. To define a deeper ellipsoidal geometry the ratio inbetween the major elliptical semi axis “c” and the minor elliptical semiaxis “b” (see FIG. 7 ) should be larger than 1.9 (c/b≥1.9). Thedimension of the reflector's largest diameter can be 50-150 mm,preferable 70-140 mm. The input high voltage discharge in F₁ (spark-gap41 formed by the first electrode 45A and second electrode 45B) can be inbetween 14-30 kV. The high voltage for the first electrode 45A and thesecond electrode 45B is provided by the power supply 95 (included incontrol console/unit 96) via high voltage cable 94. The proposedconstruction of the special full-ellipsoidal applicator 310 is using90-95% of the ellipsoid (increased reflective area surface), comparedwith classic approach (semi-ellipsoidal reflector 42 presented for otherembodiments) where only 50% of the ellipsoid surface is used to focusthe focused acoustic pressure shockwaves 40. The use of 90-95% of theellipsoidal surface is done by combining a lower shell 311 with adistinctive upper shell 312, that are connected together via the shellsconnecting ring 313. This design provides a much higher efficiency inshockwave transmission, focusing, and a larger reflector cavity 43,which is filled with a fluid that plays a role in producing, focusing,and transmitting the focused acoustic pressure shockwaves 40 towards theendoscope 30 or the reusable contaminated tubing 30. The upper shell 312of the special full-ellipsoidal applicator 310 has two upper shellcircular openings 314 that are connected with a cylindrical couplingmembrane 315 that allows the passing of the endoscope 30 or of thereusable contaminated tubing 30 through the focal volume 301 withoutinterference. The cylindrical coupling membrane 315 fits the diameter ofthe upper shell circular openings 314 and has the cylindrical couplingmembrane internal diameter 316 that allows the easy passing through itof the endoscope 30 or of the reusable contaminated tubing 30 that ispassing through the upper shell circular openings 314 and cylindricalcoupling membrane 315. The cylindrical coupling membrane internaldiameter 316 is designed in such way that the cylindrical couplingmembrane 315 does not have any contact with the endoscope 30 or thereusable contaminated tubing 30, as seen in FIG. 31 . Conversely, thecylindrical coupling membrane internal diameter 316 can be decreased toallow the cylindrical coupling membrane 315 to have close contact withthe endoscope 30 or the reusable contaminated tubing 30. The reflectorcavity 43 formed in between the lower shell 311 and upper shell 312 isfilled completely with a fluid to allow the proper propagation andfocusing of the focused acoustic pressure shockwaves 40. The lumen orlumens of the endoscope 30 or of the reusable contaminated tubing 30 arealso filled with the decontamination fluid 205 to facilitate the properaction of the focused acoustic pressure shockwaves 40 that are used foraccomplishing the complete dislodging and destruction of thecontamination layer/biofilm 204 (shown in FIGS. 20B and 23 and notspecifically in FIG. 31 ).

FIGS. 32A and 32B present a view and a different cross-section of theembodiment from FIG. 31 , to provide an even better understanding ofthis embodiment. The cross-section A-A depicts the focal volume 301 thatis spherical in nature and it is centered in the second focal point F₂of the special full-ellipsoidal applicator 310 (see FIG. 31 ). The sizeof the focal volume 301 is large enough to completely cover the fulldiametric dimension of the endoscope 30 or the reusable contaminatedtubing 30, to assure a proper cleaning and decontamination. Also, to beable to cover the full length of the endoscope 30 or of the reusablecontaminated tubing 30, requires the endoscope/tubing to constantly movein the tubing/endoscope moving direction 92 through the upper shellcircular openings 314 and cylindrical coupling membrane 315. Finally, ifthe cylindrical coupling membrane 315 is in close contact with theexternal surface of the endoscope 30 or the reusable contaminated tubing30, then there is no need to have any liquid bath 93, which willdecrease the overall dimension of the cleaning and disinfection system.When there is no contact in between the cylindrical coupling membrane315 and the external surface of the endoscope 30 or the reusablecontaminated tubing 30, then there is a need to have the liquid bath 93(not shown in FIG. 32 ) to allow the proper action of the focusedacoustic pressure shockwaves 40 on both the external surface andinternal lumen/lumens of the endoscope 30 or the reusable contaminatedtubing 30.

FIGS. 33A, 33B, and 33C show multiple three-dimensional views of thesystem that was presented in detail and its specific functioningdescribed before in FIGS. 31, 32A, and 32B. In FIGS. 33A, 33B, and 33Call the elements and their numerical depiction are the same as thosefrom FIGS. 31, 32A, and 32B.

Although the embodiment presented in FIGS. 31, 32A, 32B, 33A, 33B, and33C shows specifically an electrohydraulic system that uses thespark-gap 41, the special full-ellipsoidal applicator 310 can alsoproduce focused acoustic pressure shockwaves 40 using electrohydraulicgenerators with lasers. To assure the complete cleaning anddecontamination on the full length of medical devices such as endoscopes30, or of the reusable contaminated tubing 30 from respirators,hemodialysis units and any other medical devices, either thecontaminated device/part needs to move or alternatively the specialfull-ellipsoidal applicator 310 moves and sometimes both, using manuallyor motorized automatic means.

The embodiment from FIGS. 34A, 34B, and 34C shows multiple views and across-section of a special full-ellipsoidal applicator 310 that has theupper shell U-shape lateral opening 340, which can be used for thecleaning and decontamination of endoscopes 30 or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices. The upper shell U-shape lateral opening 340allows the accommodation a much larger range of dimensions for theendoscopes 30 or of the reusable contaminated tubing 30, when comparedwith the embodiment from FIGS. 31, 32A, 32B, 33A, 33B, and 33C. Also,the upper shell U-shape lateral opening 340 permits a much easierloading of the endoscope 30 or the reusable contaminated tubing 30, whencompared with the embodiment from FIGS. 31, 32A, 32B, 33A, 33B, and 33C.However, the embodiment from FIGS. 34A, 34B, and 34C will require theoperator to more closely monitor the movement of the endoscope 30 or thereusable contaminated tubing 30 in the tubing/endoscope moving direction92, to be sure that it remains in the proper position in the lateralslot throughout the whole cleaning and decontamination process. Themonitoring can be done visually by the operator or by using an automaticsystem and special guiding fixtures to have the endoscope 30 or thereusable contaminated tubing 30 constantly going through the focalvolume 301 centered in F₂ (focal volume 301 is not shown in FIGS. 34A.34B, and 34C for clarity).

The input high voltage discharge in F₁ (spark-gap 41 formed by the firstelectrode 45A and second electrode 45B) can be in between 14-30 kV. Thehigh voltage for the first electrode 45A and the second electrode 45B isprovided by the power supply 95 (included in control console/unit 96)via high voltage cable 94. The proposed construction of the specialfull-ellipsoidal applicator 310 is using a lower shell 311 with adistinctive upper shell 312, that are connected together via the shellsconnecting ring 313. This design provides a much higher efficiency inshockwave transmission, focusing, and a larger reflector cavity 43,which is filled with a fluid that plays a role in producing, focusing,and transmitting the focused acoustic pressure shockwaves 40 towards theendoscope 30 or the reusable contaminated tubing 30. The upper shell 312of the special full-ellipsoidal applicator 310 has the upper shellU-shape lateral opening 340 that is sealed by the lateral U-shapecoupling membrane 341 that allows the passing of the endoscope 30 or ofthe reusable contaminated tubing 30 through the focal volume 301 withoutinterference. The lateral U-shape coupling membrane 341 fits thediameter of the endoscope 30 or of the reusable contaminated tubing 30that is passing through the upper shell U-shape lateral opening 340 andlateral U-shape coupling membrane 341. There can be a direct contact orno contact of the lateral U-shape coupling membrane 341 with theendoscope 30 or the reusable contaminated tubing 30, as needed for eachsituation. The reflector cavity 43 formed in between the lower shell 311and upper shell 312 is filled completely with a fluid to allow theproper propagation and focusing of the focused acoustic pressureshockwaves 40. The lumen or lumens of the endoscope 30 or of thereusable contaminated tubing 30 are also filled with the decontaminationfluid 205 to facilitate the proper action of the focused acousticpressure shockwaves 40 for accomplishing the complete dislodging anddestruction of the contamination layer/biofilm 204 (shown in FIGS. 20Band 23 and not specifically in FIGS. 34A-34C).

The focal volume 301 produced by the special full-ellipsoidal applicator310 is spherical in nature and it is centered in the second focal pointF₂ of the special full-ellipsoidal applicator 310 (as seen in FIGS. 30and 32B and not shown in FIGS. 34A-34C for simplicity). The size of thefocal volume 301 is large enough to completely cover the full diametricdimension of the endoscope 30 or the reusable contaminated tubing 30, toassure a proper cleaning and decontamination. Also, to be able to coverthe full length of the endoscope 30 or of the reusable contaminatedtubing 30, requires the endoscope/tubing to constantly move in thetubing/endoscope moving direction 92 through the upper shell U-shapelateral opening 340 and lateral U-shape coupling membrane 341. Finally,there is a need to have the liquid bath 93 (not shown in FIGS. 34A-34C)to allow the proper action of the focused acoustic pressure shockwaves40 on both the external surface and internal lumen/lumens of theendoscope 30 or the reusable contaminated tubing 30.

Although the embodiment presented in FIGS. 34A-34C shows specifically anelectrohydraulic system that uses the spark-gap 41, the specialfull-ellipsoidal applicator 310 can also produce focused acousticpressure shockwaves 40 using electrohydraulic generators with lasers. Toassure the complete cleaning and decontamination on the full length ofmedical devices such as endoscopes 30, or of the reusable contaminatedtubing 30 from respirators, hemodialysis units and any other medicaldevices, either the contaminated device/part needs to move oralternatively the special full-ellipsoidal applicator 310 moves andsometimes both, using manually or motorized automatic means.

The embodiment from FIGS. 35A, 35B, and 35C shows multiple views and across-section of a special full-ellipsoidal applicator 310 that has theupper shell U-shape upward opening 350, which can be used for thecleaning and decontamination of endoscopes 30 or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices. The upper shell U-shape upward opening 350 allowsthe accommodation a much larger range of dimensions for the endoscopes30 or of the reusable contaminated tubing 30, when compared with theembodiment from FIGS. 31, 32A-32B, and 33A-33C. Also, the upper shellU-shape upward opening 350 permits a much easier loading of theendoscope 30 or the reusable contaminated tubing 30, when compared withthe embodiment from FIGS. 31, 32A-32B, and 33A-33C. However, theembodiment from FIGS. 35A, 35B, and 35C will require the operator tomore closely monitor the movement of the endoscope 30 or the reusablecontaminated tubing 30 in the tubing/endoscope moving direction 92, tobe sure that it remains in the proper position in the top slotthroughout the whole cleaning and decontamination process. Themonitoring can be done visually by the operator or by using an automaticsystem and special guiding fixtures to have the endoscope 30 or thereusable contaminated tubing 30 constantly going through the focalvolume 301 centered in F₂ (focal volume 301 is not shown in FIGS.35A-35C for clarity).

The input high voltage discharge in F (spark-gap 41 formed by the firstelectrode 45A and second electrode 45B) can be in between 14-30 kV. Thehigh voltage for the first electrode 45A and the second electrode 45B isprovided by the power supply 95 (included in control console/unit 96)via high voltage cable 94. The proposed construction of the specialfull-ellipsoidal applicator 310 is using a lower shell 311 with adistinctive upper shell 312, that are connected together via the shellsconnecting ring 313. This design provides a much higher efficiency inshockwave transmission, focusing, and a larger reflector cavity 43,which is filled with a fluid that plays a role in producing, focusing,and transmitting the focused acoustic pressure shockwaves 40 towards theendoscope 30 or the reusable contaminated tubing 30. The upper shell 312of the special full-ellipsoidal applicator 310 has the upper shellU-shape upward opening 350 that is sealed by the upward U-shape couplingmembrane 351 that allows the passing of the endoscope 30 or of thereusable contaminated tubing 30 through the focal volume 301 withoutinterference. The upward U-shape coupling membrane 351 fits the diameterof the endoscope 30 or of the reusable contaminated tubing 30 that ispassing through the upper shell U-shape upward opening 350 and upwardU-shape coupling membrane 351. There can be a direct contact or nocontact of the upward U-shape coupling membrane 351 with the endoscope30 or the reusable contaminated tubing 30, as needed for each situation.The reflector cavity 43 formed in between the lower shell 311 and uppershell 312 is filled completely with a fluid to allow the properpropagation and focusing of the focused acoustic pressure shockwaves 40.The lumen or lumens of the endoscope 30 or of the reusable contaminatedtubing 30 are also filled with the decontamination fluid 205 tofacilitate the proper action of the focused acoustic pressure shockwaves40 for accomplishing the complete dislodging and destruction of thecontamination layer/biofilm 204 (shown in FIGS. 20B and 23 and notspecifically in FIGS. 35A-35C).

The focal volume 301 produced by the special full-ellipsoidal applicator310 is spherical in nature and it is centered in the second focal pointF₂ of the special full-ellipsoidal applicator 310 (as seen in FIGS. 30and 32B and not shown in FIGS. 35A-35C for simplicity). The size of thefocal volume 301 is large enough to completely cover the full diametricdimension of the endoscope 30 or the reusable contaminated tubing 30, toassure a proper cleaning and decontamination. Also, to be able to coverthe full length of the endoscope 30 or of the reusable contaminatedtubing 30, requires the endoscope/tubing to constantly move in thetubing/endoscope moving direction 92 through the upper shell U-shapeupward opening 350 and upward U-shape coupling membrane 351. Finally,there is a need to have the liquid bath 93 (not shown in FIG. 35 ) toallow the proper action of the focused acoustic pressure shockwaves 40on both the external surface and internal lumen/lumens of the endoscope30 or the reusable contaminated tubing 30.

Although the embodiment presented in FIGS. 35A-35C shows specifically anelectrohydraulic system that uses the spark-gap 41, the specialfull-ellipsoidal applicator 310 can also produce focused acousticpressure shockwaves 40 using electrohydraulic generators with lasers. Toassure the complete cleaning and decontamination on the full length ofmedical devices such as endoscopes 30, or of the reusable contaminatedtubing 30 from respirators, hemodialysis units and any other medicaldevices, either the contaminated device/part needs to move oralternatively the special full-ellipsoidal applicator 310 moves andsometimes both, using manually or motorized automatic means.

In the embodiments from FIGS. 31-35C only one special full-ellipsoidalapplicator 310 was used for the cleaning and decontamination of theendoscopes 30, or of the reusable contaminated tubing 30 fromrespirators, hemodialysis units, and any other medical devices. Toincrease efficiency and reduce duration of the cleaning anddecontamination, multiple special full-ellipsoidal applicators 310 canbe used, by arranging them in a sequential manner, as it is presented inthe embodiment from FIG. 36 . The full-ellipsoidal applicators 310 withthe upper shell U-shape lateral opening 340 and lateral U-shape couplingmembrane 341 are exemplified in FIG. 36 . However, full-ellipsoidalapplicators 310 with the upper shell U-shape upward opening 350 andupward U-shape coupling membrane 351 can also be used. The cleaning anddecontamination system from FIG. 36 has a total of four applicators thatinclude the first laterally-slotted full ellipsoidal applicator 360, thesecond laterally-slotted full ellipsoidal applicator 361, the thirdlaterally-slotted full ellipsoidal applicator 362, and the fourthlaterally-slotted full ellipsoidal applicator 363. The four applicators360, 361, 362, and 363 are all constructed by using a lower shell 311and a distinctive upper shell 312, that are connected together via theshells connecting ring 313. To provide a more efficient spatialdistribution, all four applicators 360, 361, 362, and 363 are rotatedwith 90 degrees back and forth along the endoscope 30 or the reusablecontaminated tubing 30. There might be other embodiments that can havemore than four applicators, depending on the type of endoscope 30 or thereusable contaminated tubing 30 and the efficiency or duration of thecleaning and high-level disinfection process.

For the embodiment from FIG. 36 , a liquid bath 93 is needed to allowthe proper action of the waves 40 (including in respective embodimentsfocused acoustic pressure shockwaves, pseudo-planar pressure waves oracoustic radial pressure waves) on both the external surface andinternal lumen/lumens of the endoscope 30 or the reusable contaminatedtubing 30. The liquid bath 93 and the focused acoustic pressureshockwaves 40 are not shown in FIG. 36 for simplicity. Also, for a goodcleaning and high-level disinfection on the full length of theendoscopes 30, or of the reusable contaminated tubing 30 fromrespirators, hemodialysis units, and any other medical devices, theendoscopes/tubes need to move in the tubing/endoscope moving direction92. The operator needs to closely monitor the movement of the endoscope30 or the reusable contaminated tubing 30 to be sure that it remains inthe proper position in the dedicated slot of the applicators 360, 361,362, and 363 throughout the whole cleaning and decontamination process.The monitoring can be done visually by the operator or by using anautomatic system and special guiding fixtures to have the endoscope 30or the reusable contaminated tubing 30 constantly going through thefocal volumes 301 centered in F₂ (not shown in FIG. 36 for clarity).

The embodiment presented in FIG. 36 shows specifically, the specialfull-ellipsoidal applicator 310 can produce focused acoustic pressureshockwaves 40 using an electrohydraulic system that uses the spark-gap41 or electrohydraulic generators with lasers. To assure the completecleaning and decontamination on the full length of medical devices suchas endoscopes 30, or of the reusable contaminated tubing 30 fromrespirators, hemodialysis units and any other medical devices, eitherthe contaminated device/part needs to move or alternatively theapplicators 360, 361, 362, and 363 can move in synchronicity andsometimes both (applicators and endoscope/tubing), using manually ormotorized automatic means.

The embodiment from FIG. 37 is a decontamination piezoelectric system370 that is capable to easily generate acoustic planar pressure waves374 by using piezoelectric elements 375, such as flat piezocrystals/piezo ceramics or a piezo fiber layer. These decontaminationpiezoelectric systems 370 can be used to generate acoustic planarpressure waves 374 and direct them towards endoscopes 30 or the reusablecontaminated tubing 30. In order to get the applicator 97 in contactwith the surface of an endoscope 30 or reusable contaminated tubing 30,the applicator 97 is moved via transversal (T) and longitudinal (L)motions. By applying an electrical field to piezoelectric elements 375(such as flat piezo crystals/piezo ceramics or a piezo fiber layer)uniformly placed on the central core 371 (can be cylindrical, square,hexagonal, octagonal or decagonal, etc.), a mechanical strain isresulting that produces acoustic planar pressure waves 374 inside thefluid-filled lateral semi-cylindrical coupling membrane 373. Theelectrical field for the piezoelectric element 375—crystals/piezoceramics or for the piezo fiber layer—is provided via high voltage cable94 by the power supply 95, which is included in control console/unit 96.On its upper part the applicator 97 has an upper cover 372 that is thesupport for the lateral semi-cylindrical coupling membrane 373 and alsoit helps with the correct orientation of the applicator 97 to properlydirect the acoustic planar pressure waves 374 to pass through theendoscope 30 or reusable contaminated tubing 30. For the constructionthat uses the piezo crystals/piezo ceramics, individual or multiplepiezo crystals/piezo ceramics can be activated concomitantly orsequentially, which can tailor the delivery of the acoustic planarpressure waves 374 based on explicit needs of the cleaning anddecontamination process.

For the embodiment from FIG. 37 , a liquid bath 93 and associated liquidbath enclosure 171 are needed to allow the proper action of the acousticplanar pressure waves 374 on both the external surface and internallumen/lumens of the endoscope 30 or the reusable contaminated tubing 30.Also, for a good cleaning and high-level disinfection on the full lengthof the endoscopes 30, or of the reusable contaminated tubing 30 fromrespirators, hemodialysis units, and any other medical devices, theyneed to move in the tubing/endoscope moving direction 92. To notincrease considerable the dimensions of the liquid bath 93 andassociated liquid bath enclosure 171, the endoscope 30 and the reusablecontaminated tubing 30 can enter and exit the liquid bath 93 immediatelybefore and after passing in front of the acoustic planar pressure waves374. To assure the complete cleaning and decontamination on the fulllength of medical devices such as endoscopes 30, or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices, either the contaminated device/part needs to moveor alternatively the applicator 97 moves and sometimes both, usingmanually or motorized automatic means.

FIG. 38A shows the features characteristic of the ultrasound pressurewaves, which were discussed in detail previously when all type ofshockwaves or pressure waves were compared at the beginning at thisinvention. FIG. 38B presents an embodiment that uses low frequencyultrasound waves (main ultrasound waves 380 and secondary ultrasoundwaves 381) for cleaning and high-level disinfection of endoscopes 30 orreusable contaminated tubing 30 from ventilators and dialysis machinesor from any other medical devices.

Inside the ultrasound applicator 382 and also inside theapplicator/coupling membrane 44, there is a central metal acoustic horn384 that amplifies the vibration of the piezo crystal/piezo ceramic(placed inside the ultrasound applicator 382 body and not specificallyshown in FIG. 38B) towards the ultrasound-generating main plate 383,which is used to produce the main ultrasound waves 380. Theultrasound-generating piezo crystal/piezo ceramic (placed inside theultrasound applicator 382 body and not specifically shown in FIG. 38B)converts and transfers the input electrical power received via powercable 94 from the power supply 95 (included in the control console/unit96) into vibrational mechanical (ultrasonic) energy that will bedelivered via the ultrasound transmission fluid 385 and theapplicator/coupling membrane 44 for the cleaning and high-leveldisinfection of endoscopes 30 or reusable contaminated tubing 30 fromventilators and dialysis machines or from any other medical devices. Theacoustic horn 384 is used to amplify the excitation of theultrasound-generating piezo crystal/piezo ceramic into the properultrasound amplitude 388A (see FIG. 38A) and thus produce more robustand energetic main ultrasound waves 380 that exit theapplicator/coupling membrane 44 along the central longitudinal axis ofthe ultrasound applicator 382. The ultrasound waves 380 are mainly usedfor the cleaning and decontamination of the interior channels 170 of theendoscopes 30 or lumen or lumens of reusable contaminated tubing 30.

The same ultrasound applicator 382 has two circumferential, external,and opposite (positioned 180-degrees apart) ultrasound-generatingsecondary piezo crystal/piezo ceramic 386 that are producing thesecondary ultrasound waves 381, which are used to clean the interiorchannels 170 of the endoscopes 30 or lumen or lumens of reusablecontaminated tubing 30 and also the exterior surface of theendoscope/tubing. The ultrasound-generating secondary piezocrystal/piezo ceramic 386 are mounted on the ultrasound applicator 382in such way that they are capable of having a swiveling motion S arounda pivoting point, which helps to adapt to the possible texture orvariations in the external surface of the endoscope 30 or reusablecontaminated tubing 30, as seen for example in FIG. 38B that shows acorrugated tubing.

The ultrasound-generating main plate 383 and also theultrasound-generating secondary piezo crystal/piezo ceramic 386 haveradial surfaces to be able to radiate the main ultrasound waves 380 andsecondary ultrasound waves 381 in a radial/spherical manner. In order toget the ultrasound applicator 382 in contact with the surface of anendoscope 30 or reusable contaminated tubing 30, the ultrasoundapplicator 382 is moved via transversal (T) and longitudinal (L)motions. To assure the complete cleaning and decontamination on the fulllength of medical devices such as endoscopes 30, or of the reusablecontaminated tubing 30 from respirators, hemodialysis units and anyother medical devices, either the contaminated device/part needs to moveor alternatively the ultrasound applicator 382 moves and sometimes both,using manually or motorized automatic means. In FIG. 38B the endoscope30, or reusable contaminated tubing 30 from respirators or hemodialysisunits or from any other medical devices) is moving in thetubing/endoscope moving direction 92 and in front of the main ultrasoundwaves 380 and secondary ultrasound waves 381.

For FIG. 38B, since the main ultrasound waves 380 and secondaryultrasound waves 381 need to be produced in a liquid medium, in order tonot lose energy through reflections at the change of acoustic impedancefrom one medium to another and fully take advantage of the micro-jetsproduced by the collapse of cavitation bubbles, the endoscope 30 or thereusable contaminated tubing 30 are placed into liquid bath 93 and theirlumen/lumens filled with a decontamination fluid 205 (see FIGS. 20B and21B). For a good cleaning and high-level disinfection on the full lengthof the endoscopes 30, or of the reusable contaminated tubing 30 fromrespirators, hemodialysis units, and any other medical devices, theyneed to move in the tubing/endoscope moving direction 92. To notincrease considerable the dimensions of the liquid bath 93, theendoscope 30 and the reusable contaminated tubing 30 can enter and exitthe liquid bath 93 immediately before and after passing in front of themain ultrasound waves 380 and secondary ultrasound waves 381. To assurethe complete cleaning and decontamination on the full length of medicaldevices such as endoscopes 30, or of the reusable contaminated tubing 30from respirators, hemodialysis units and any other medical devices,either the contaminated device/part needs to move or alternatively theultrasound applicator 382 moves and sometimes both, using manually ormotorized automatic means.

In the embodiment from FIG. 39 the decontamination system with multipleradial pressure waves 390 is using the acoustic radial pressure wave 40that are generated via multiple high voltage discharges, which is theelectrohydraulic principle using high voltage discharges across thespark-gaps 41 seen in FIG. 4 that are overlapping with F₁, F₂, and F₃points, which are spread equally along the longitudinal axis of theapplicator 97. As shown in this figure, there are three high voltagedischarges produced in a fluid-filled volume 392 created in between thecylindrical coupling membrane 391 and the body of the applicator 97. Thefirst spark-gap discharge in F₁ is produced in between first electrode45A and the second electrode 45B, the second spark-gap discharge in F₂is produced in between third electrode 45A′ and the fourth electrode45B′, and the third spark-gap in F₃ is produced in between fifthelectrode 45A″ and the sixth electrode 45B″. The high voltage for eachpair of electrodes is provided from independent power supplies to allowa proper discharge without interference from the other pairs ofelectrodes. Thus, the discharge in F₁ produced in between firstelectrode 45A and the second electrode 45B is powered by the first powersupply 95A, the discharge in F₂ produced in between third electrode 45A′and the fourth electrode 45B′ is powered by the second power supply 95B,and the discharge in F₃ produced in between fifth electrode 45A″ and thesixth electrode 45B″ is powered by the third power supply 95C. The powersupplies 95A, 95B, and 95C are all included in the control console/unit96 and are connected with the applicator 97 via high voltage cable 94.In an alternative embodiment, a single power supply 95 (as seen in FIGS.9-17B, 19A-22, 24-25B, 27, 31-32B, 34B, 35B, 37, and 38B) that can beused to power all three pairs of electrodes. For this embodiment, thefirst pair of electrodes 45A and 45B, the second pair of electrodes 45A′and 45B′, and the third pair of electrodes 45A″ and 45B″ can beactivated concomitantly or sequentially, based on specific needs of thecleaning and decontamination. Furthermore, only two pairs of electrodescan be used or even only one of the pairs of electrodes can beactivated, which can tailor the delivery of the acoustic radial pressurewaves 40 on specific locations of the endoscope 30 and the reusablecontaminated tubing 30.

Due to its construction the decontamination system with multiple radialpressure waves 390 is cleaning and decontaminating simultaneously twoendoscopes 30 or two reusable contaminated tubing/tubes 30 that aremoving in opposite tubing/endoscope moving directions 92 through the ofthe acoustic radial pressure waves 40. There is no reflector present inthis embodiment presented in FIG. 39 and this is why when the spark-gapdischarges are produced, the associated plasma bubbles expand andcollapse transforming the heat into kinetic energy in the form ofspherical waves known as acoustic radial pressure waves 40. Due to thespherical nature of the acoustic pressure waves produced by theapplicator 97 of this embodiment, the acoustic radial pressure waves 40will propagate in all directions. The applicator 97 has only a portionof the cylindrical coupling membrane 391 in contact with the endoscopes30 and the reusable contaminated tubing/tubes 30, and this is why only aportion of the spherical pressure waves/acoustic radial pressure waves40 are transmitted through the endoscopes 30 and the reusablecontaminated tubing/tubes 30. The rest of the spherical pressurewaves/acoustic radial pressure waves 40 are transmitted away and inbetween the endoscopes 30 and the reusable contaminated tubing/tubes 30.However, the symmetrical and rotational nature of the applicator 97,offer ease-of-use for the personnel, who does not have to choose apreferred/specific position for the applicator 97 during cleaning anddecontaminating process. In order to get the applicator 97 in contactwith the surface of an endoscope 30 or reusable contaminated tubing 30,the applicator 97 is moved via transversal (T) and longitudinal (L)motions.

For FIG. 39 , since the acoustic radial pressure waves 40 need to beproduced in a liquid medium, in order to not lose energy throughreflections at the change of acoustic impedance from one medium toanother and fully take advantage of the micro-jets produced by thecollapse of cavitation bubbles, the two endoscopes 30 or the reusablecontaminated tubing/tubes 30 are placed into liquid bath 93 from insidethe liquid bath enclosure 171 and their lumen/lumens filled with adecontamination fluid 205 (see FIGS. 20B and 21B). For a good cleaningand high-level disinfection on the full length of the endoscopes 30, orof the reusable contaminated tubing/tubes 30 from respirators,hemodialysis units, and any other medical devices, they need to move inthe tubing/endoscope moving directions 92. To not increase considerablethe dimensions of the liquid bath 93 and the liquid bath enclosure 171,the endoscope 30 and the reusable contaminated tubing/tubes 30 can enterand exit the liquid bath 93 immediately before and after passing infront of the acoustic radial pressure waves 40. To assure the completecleaning and decontamination on the full length of medical devices suchas endoscopes 30, or of the reusable contaminated tubing/tubes 30 fromrespirators, hemodialysis units and any other medical devices, eitherthe contaminated devices/parts need to move or alternatively theapplicator 97 moves and sometimes both, using manually or motorizedautomatic means.

In the embodiment from FIG. 40 the decontamination system with multipleradial pressure waves 390 is using the acoustic radial pressure waves 40that are generated via multiple laser sources (electrohydraulicprinciple using multiple lasers sources) that are equally spread alongthe longitudinal axis of the applicator 97. There are three pairs ofincased lasers that are producing laser beams and plasma bubbles in afluid-filled volume 392 created in between the cylindrical couplingmembrane 391 and the body of the applicator 97. The first incased laser45C and the second incased laser 45D represent the first pair of encasedlasers that produces laser beams in F₁, the third incased laser 45C′ andthe fourth incased laser 45D′ represent the second pair of encasedlasers that produces laser beams in F₂, and the fifth incased laser 45C″and sixth incased laser 45D″ represent the third pair of encased lasersthat produces laser beams in F₃. In one embodiment, the high voltage foreach pair of encased lasers is provided from independent power supplies.Thus, the first incased laser 45C and the second incased laser 45D arepowered by the first power supply 95A, the third incased laser 45C′ andthe fourth incased laser 45D′ are powered by the second power supply95B, and the fifth incased laser 45C″ and sixth incased laser 45D″ arepowered by the third power supply 95C. In another embodiment all thelasers are powered by only one power source/supply 95, as seen in FIGS.9-17B, 19A-22, 24-25B, 27, 31-32B, 34B, 35B, 37, and 38B, that useslaser splitters (not shown) to split energy in between different encasedlasers. Regardless of design, the power source/supply 95 or sources(95A, 95B, and 95C) are included in the control console/unit 96 and areconnected with the applicator 97 via high voltage cable 94. For thisembodiment, the first pair of encased lasers 45C and 45D, the secondpair of encased lasers 45C′ and 45D′, and the third pair of encasedlasers 45C″ and 45D″ can be activated concomitantly or sequentially.Furthermore, only two pairs of encased lasers can be used or even onlyone of the pairs of encased lasers can be activated, which can tailorthe treatment on delivering the acoustic radial pressure waves 40 onspecific locations of the endoscopes 30 and the reusable contaminatedtubing/tubes 30.

To control the good functionality of the lasers there are means ofmonitoring the system performance by measuring the reaction temperatureof the plasma bubble collapse using a method of optical fiberthermometry, which are not specifically shown in FIG. 40 , but wereshown in detail in FIG. 12 . Also, in this embodiment there is noreflector present and this is why when the lasers discharges areproduced, the associated plasma bubbles expand and collapse transformingthe heat into kinetic energy in the form of spherical waves known asacoustic radial pressure waves 40. Due to the spherical nature of theacoustic pressure waves produced by the applicator 97 of thisembodiment, the acoustic radial pressure waves 40 will propagate in alldirections. The applicator 97 has only a portion of the cylindricalcoupling membrane 391 in contact with the endoscopes 30 and the reusablecontaminated tubing/tubes 30, and this is why only a portion of thespherical pressure waves/acoustic radial pressure waves 40 aretransmitted through the endoscopes 30 and the reusable contaminatedtubing/tubes 30. The rest of the spherical pressure waves/acousticradial pressure waves 40 are transmitted away and it between theendoscopes 30 and the reusable contaminated tubing/tubes 30. However,the symmetrical and rotational nature of the applicator 97, offerease-of-use for the personnel, who does not have to choose apreferred/specific position for the applicator 97 during cleaning anddecontaminating process. In order to get the applicator 97 in contactwith the surface of an endoscope 30 or reusable contaminated tubing 30,the applicator 97 is moved via transversal (T) and longitudinal (L)motions.

For FIG. 40 , since the acoustic radial pressure waves 40 need to beproduced in a liquid medium, in order to not lose energy throughreflections at the change of acoustic impedance from one medium toanother and fully take advantage of the micro-jets produced by thecollapse of cavitation bubbles, the two endoscopes 30 or the reusablecontaminated tubing/tubes 30 are placed into liquid bath 93 from insidethe liquid bath enclosure 171 and their lumen/lumens filled with adecontamination fluid 205 (see FIGS. 20B and 21B). For a good cleaningand high-level disinfection on the full length of the endoscopes 30, orof the reusable contaminated tubing/tubes 30 from respirators,hemodialysis units, and any other medical devices, they need to move inthe tubing/endoscope moving directions 92. To not increase considerablethe dimensions of the liquid bath 93 and the liquid bath enclosure 171,the endoscope 30 and the reusable contaminated tubing/tubes 30 can enterand exit the liquid bath 93 immediately before and after passing infront of the acoustic radial pressure waves 40. To assure the completecleaning and decontamination on the full length of medical devices suchas endoscopes 30, or of the reusable contaminated tubing/tubes 30 fromrespirators, hemodialysis units and any other medical devices, eitherthe contaminated devices/parts need to move or alternatively theapplicator 97 moves and sometimes both, using manually or motorizedautomatic means.

To increase efficiency and reduce duration of the cleaning anddecontamination, an array of multiple platform applicators 410-413 canbe used, by arranging them in a sequential manner, as it is presented inthe embodiment from FIG. 41 . The cleaning and decontamination arrayfrom FIG. 41 has a total of four applicators that include the firstplatform applicator 410, the second platform applicator 411, the thirdplatform applicator 412, and the fourth platform applicator 413. Thefour platform applicators 410, 411, 412, and 413 are all constructed byusing a lower shell 311 and a distinctive L-shape upper shell 414, whichare connected together via the shells connecting ring 313. On the top ofthe aperture of the L-shape upper shells 414 sits a correspondingL-shape coupling membranes 415. In this way, an enclosed space filledwith fluid is created in which the pressure waves, such as pseudo-planarpressure waves 40 or acoustic radial pressure waves 40 or unfocusedpressure waves, are created. To provide a more efficient spatialdistribution, all four platform applicators 410, 411, 412, and 413 arerotated with 180 degrees and positioned on the same side and along theendoscope 30 or the reusable contaminated tubing 30. There might beother embodiments that can have more than four applicators, depending onthe type of endoscope 30 or the reusable contaminated tubing 30 and theefficiency or duration of the cleaning and high-level disinfectionprocess.

For the embodiment from FIG. 41 , a liquid bath 93 is needed to allowthe proper action of the pseudo-planar pressure waves 40 or of theacoustic radial pressure waves 40 or of the unfocused pressure waves onboth the external surface and internal lumen/lumens of the endoscope 30or the reusable contaminated tubing 30. The liquid bath 93 and thepseudo-planar pressure waves 40 or the acoustic radial pressure waves 40or unfocused pressure waves are not shown in FIG. 41 for simplicity.Also, for a good cleaning and high-level disinfection on the full lengthof the endoscopes 30, or of the reusable contaminated tubing 30 fromrespirators, hemodialysis units, and any other medical devices, theendoscopes/tubes need to move in the tubing/endoscope moving direction92. The operator needs to closely monitor the movement of the endoscope30 or the reusable contaminated tubing 30 to be sure that it remains inthe proper position on the platform of the platform applicators 410,411, 412, and 413 and in close contact with the L-shape couplingmembranes 415 throughout the whole cleaning and decontamination process.The monitoring can be done visually by the operator or by using anautomatic system and special guiding fixtures to have the endoscope 30or the reusable contaminated tubing 30 constantly in the proper positionrelatively to the platform applicators 410, 411, 412, and 413.

For the embodiment presented in FIG. 41 the platform applicators 410,411, 412, and 413 can use all types of generation principles forcreating pseudo-planar pressure waves 40 or the acoustic radial pressurewaves 40 or unfocused pressure waves using electrohydraulic generators(with spark-gaps or lasers), piezoelectric generators (with piezocrystals/piezo ceramics or piezo fibers) or electromagnetic generators(with flat coils or cylindrical coils). To assure the complete cleaningand decontamination on the full length of medical devices such asendoscopes 30, or of the reusable contaminated tubing 30 fromrespirators, hemodialysis units and any other medical devices, eitherthe contaminated device/part needs to move or alternatively the platformapplicators 410, 411, 412, and 413 can move in synchronicity andsometimes both (applicators and endoscope/tubing), using manually ormotorized automatic means. In FIG. 41 the endoscope 30, or reusablecontaminated tubing 30 from respirators or hemodialysis units or fromany other medical devices is moving in the tubing/endoscope movingdirection 92 and in front of the pseudo-planar pressure waves 40 or theacoustic radial pressure waves 40 or unfocused pressure waves.

Another way to increase efficiency and reduce duration of the cleaningand decontamination, an array of multiple double-applicators 420-423 canbe used, by arranging them in a sequential manner, as it is presented inthe embodiment from FIGS. 42A and 42B. The cleaning and decontaminationarray from FIGS. 42A and 42B has a total of four applicators thatinclude the first double-applicator 420, the second double-applicator421, the third double-applicator 422, and the fourth double-applicator423. The four double-applicators 420, 421, 422, and 423 are allconstructed by using an upper applicator 424 and the lower applicator425, which are connected together via the assembly ring 426. In themiddle section of the double applicators 420-423 and on the top of theirapertures sits a U-shape symmetric membrane 427. In this way an enclosedspace filled with fluid is created in which the pseudo-planar pressurewaves 40 or the acoustic radial pressure waves 40 or unfocused pressurewaves are created. To provide a more efficient spatial distribution, allfour double-applicators 420, 421, 422, and 423 are rotated with 90degrees in the same direction (clockwise or counterclockwise) andpositioned along the endoscope 30 or the reusable contaminated tubing30. There might be other embodiments that can have more than fourapplicators, depending on the type of endoscope 30 or the reusablecontaminated tubing 30 and the efficiency or duration of the cleaningand high-level disinfection process.

For the embodiment from FIGS. 42A and 42B, a liquid bath 93 is needed toallow the proper action of the pseudo-planar pressure waves 40 or of theacoustic radial pressure waves 40 or of the unfocused pressure waves onboth the external surface and internal lumen/lumens of the endoscope 30or the reusable contaminated tubing 30. The liquid bath 93 and thepseudo-planar pressure waves 40 or the acoustic radial pressure waves 40or unfocused pressure waves are not shown in FIGS. 42A and 42B forsimplicity. Also, for a good cleaning and high-level disinfection on thefull length of the endoscopes 30, or of the reusable contaminated tubing30 from respirators, hemodialysis units, and any other medical devices,the endoscopes/tubes need to move in the tubing/endoscope movingdirection 92. The operator needs to closely monitor the movement of theendoscope 30 or the reusable contaminated tubing 30 to be sure that itremains in the proper position in the U-shape space of thedouble-applicators 420, 421, 422, and 423 and in close contact with theU-shape symmetric membrane 427 throughout the whole cleaning anddecontamination process. The monitoring can be done visually by theoperator or by using an automatic system and special guiding fixtures tohave the endoscope 30 or the reusable contaminated tubing 30 constantlyin the proper position relatively to the double-applicators 420, 421,422, and 423.

For the embodiment presented in FIGS. 42A and 42B the double-applicators420, 421, 422, and 423 can use all types of generation principles forcreating pseudo-planar pressure waves 40 or the acoustic radial pressurewaves 40 or unfocused pressure waves using electrohydraulic generators(with spark-gaps or lasers), piezoelectric generators (with piezocrystals/piezo ceramics or piezo fibers) or electromagnetic generators(with flat coils or cylindrical coils). To assure the complete cleaningand decontamination on the full length of medical devices such asendoscopes 30, or of the reusable contaminated tubing 30 fromrespirators, hemodialysis units and any other medical devices, eitherthe contaminated device/part needs to move or alternatively thedouble-applicators 420, 421, 422, and 423 can move in synchronicity andsometimes both (applicators and endoscope/tubing), using manually ormotorized automatic means. In FIGS. 42A and 42B the endoscope 30, orreusable contaminated tubing 30 from respirators or hemodialysis unitsor from any other medical devices is moving in the tubing/endoscopemoving direction 92 and in front of the pseudo-planar pressure waves 40or the acoustic radial pressure waves 40 or the unfocused pressurewaves.

In FIG. 43 is presented another embodiment where the multipledouble-applicators 420-423 are arranged in a sequential manner, but thistime by rotating them with 90 degrees back and forth and positionedalong the endoscope 30 or the reusable contaminated tubing 30. For thecleaning and decontamination array from FIG. 43 all the elements, theirnumerical depiction, and the array specific functioning are the same asthose described before in FIGS. 42A and 42B.

The automated endoscope reprocessors (AER) offer several advantages overmanual reprocessing since they automate and standardize severalimportant reprocessing steps, reduce the likelihood that an essentialreprocessing step will be skipped, and reduce personnel exposure tohigh-level disinfectants or chemical sterilants. Failure of AERs hasbeen linked to outbreaks of infections or colonization, and the AERwater filtration system might not be able to reliably provide “sterile”or bacteria-free rinse water. AERs need further development andredesign, as do endoscopes, to subsequently not representing a potentialsource of infectious agents.

The embodiment from FIGS. 44A, 44B, and 44C shows a cleaning anddisinfection automatic reprocessor 440 that is using the focusedacoustic pressure shockwaves 40 or pressure waves (pseudo-planarpressure waves 40 or acoustic radial pressure waves 40 or unfocusedpressure waves) to process endoscopes 30, or reusable contaminatedtubing/tubes 30 from respirators or hemodialysis units or from any othermedical devices. The cleaning and disinfection automatic reprocessors440 are formed by a reprocessor upper lid 441 and by the reprocessorbottom liquid bath 442 that are connected via the hinge 443. Thereprocessor upper lid 441 is in the shape of a semi-ellipsoidalreflector 42 to produce focused acoustic pressure shockwaves 40 orunfocused pressure waves (if the focal point 47 is beyond and outsidethe reprocessor bottom liquid bath 442) or parabolic reflector 51 toproduce focused acoustic pressure shockwaves 40 (if the parabolic focalpoint is in the reprocessor bottom liquid bath 442) or pseudo-planarpressure waves 40 (if the parabolic focal point is in the reprocessorupper lid 441) or combination semi-spherical and conical reflector 61(to produce acoustic radial pressure waves 40). The hinge 443 isallowing the reprocessor upper lid 441 to pivot relatively to thereprocessor bottom liquid bath 442 and thus to open or close shut thecleaning and disinfection automatic reprocessors 440. The reprocessorbottom liquid bath 442 has attached to it the reprocessor controlconsole 445 from where the functionality of the cleaning anddisinfection automatic reprocessors 440 is controlled. The reprocessorcontrol console 445 is designed to have processors and microprocessors,displays, input/output elements, timers, memory units, remote controldevices, independent power unit, etc. Each of these components mayinclude hardware, software, or a combination of hardware and softwareconfigured to perform one or more functions associated with providinggood functioning of the whole cleaning and disinfection automaticreprocessors 440. The reprocessor upper lid 441 has attached to its topthe reprocessor power supply 444 that provides power to the firstelectrode 45A and the second electrode 45B that are forming thespark-gap 41 that sits in F₁ that can be the first ellipsoidal focalpoint or the parabolic focal point or the sphere central point. To beeasily accessible the cleaning and disinfection automatic reprocessors440 has four legs 446. The whole volume of the cleaning and disinfectionautomatic reprocessors 440 is filled with the washing and cleaning fluid447, when the endoscopes 30 or reusable contaminated tubing/tubes 30from respirators or hemodialysis units or from any other medical devicesare cleaned and decontaminated. At their turn the endoscopes 30 orreusable contaminated tubing/tubes 30 are/is also filled withdecontamination fluid 205 (see FIGS. 20B and 21B) that can be stagnantor continuously circulated during cleaning and high-level disinfectionprocess. For this embodiment mostly the internal endoscope channels 170or the lumen/lumens of the reusable contaminated medical tubing 30 arecleaned and decontaminated. If the external surface of the endoscopes 30or reusable contaminated tubing/tubes 30 needs to be also cleaned anddecontaminated, that can be done prior to the introduction inside thecleaning and disinfection automatic reprocessors 440 or if theendoscopes 30 or reusable contaminated tubing/tubes 30 are/is suspendedin special bags positioned in the targeted zone of the reprocessorbottom liquid bath 442. The cleaning and disinfection automaticreprocessors 440 can reprocess for cleaning and decontamination one ormultiple endoscopes 30 or reusable contaminated tubing/tubes 30.

As seen from FIGS. 44A, 44B, 44C, 45A and 45B, the endoscopes 30 orreusable contaminated tubing/tubes 30 are placed in the reprocessorbottom liquid bath 442 where the focused acoustic pressure shockwaves 40produce their focal volume 48 (see FIG. 4 ) or the pseudo-planarpressure waves 40 produce their pseudo-planar waves pressure field 55(see FIG. 5 ) or acoustic radial pressure waves 40 produce their radialwaves pressure field 63 (see FIG. 6 ) or unfocused pressure waves can befound.

Although the embodiment presented in FIGS. 44A-44C shows specifically anelectrohydraulic system that uses the spark-gap 41, the cleaning anddisinfection automatic reprocessor 440 can also produce focused acousticpressure shockwaves 40 or pressure waves (pseudo-planar pressure waves40 or acoustic radial pressure waves 40 or unfocused pressure waves)using electrohydraulic generators with lasers, piezoelectric generators(with piezo crystals/piezo ceramics or piezo fibers) or electromagneticgenerators (with flat coils or cylindrical coils).

FIGS. 45A and 45B represents a three-dimensional depiction of thecleaning and disinfection automatic reprocessor 440 that had itscomponents and functionality described in detail in FIGS. 44A-44C. InFIGS. 45A and 45B the hinge 443 is in the back of the three-dimensionalrepresentation and for simplicity the reprocessor power supply 444 andreprocessor control console 445 were removed.

For increased efficiency, in FIGS. 46A and 46B is presented areprocessor with two opposite reflectors 460. Practically, thereprocessor bottom liquid bath 442 of the cleaning and disinfectionautomatic reprocessor 440 (from FIGS. 44A-45B) is replaced with anotherreflector-like structure, similar to the reprocessor upper lid 441, asseen in FIGS. 44A-45B. Thus the reprocessor with two opposite reflectors460 is formed by the top reflector 461 and the lower reflector 462. Boththese reflectors have their own focal point F from where the focusedacoustic pressure shockwaves 40 or pressure waves (pseudo-planarpressure waves 40 or acoustic radial pressure waves 40 or unfocusedpressure waves) are originating and then focused or directed towards theendoscopes 30 or reusable contaminated tubing/tubes 30 from respiratorsor hemodialysis units or from any other medical devices. One or multipleendoscopes 30 or reusable contaminated tubing/tubes 30 for thisembodiment are sitting on a platform (not shown in FIGS. 46A and 46B)that allows the shockwaves or pressure waves to go through and in thetargeted zone for the two reflectors 461 and 462, where theshockwave/pressure waves have maximum action for cleaning anddecontamination. The platform can be made of a thin plastic sheath orcan be a specially designed bag suspended in the targeted zone of thereflectors 461 and 462 of the reprocessor with two opposite reflectors460. The platform or the bag can be raised or lowered in a continuousmotion during the reprocessing to increase efficiency of the cleaningand the high-level disinfection. For this embodiment both the externalsurface and the internal endoscope channels 170 or the lumen/lumens ofthe reusable contaminated medical tubing 30 are cleaned anddecontaminated. The reprocessor with two opposite reflectors 460 canreprocess for cleaning and decontamination one or multiple endoscopes 30or reusable contaminated tubing/tubes 30. The two reflectors 461 and 462of the reprocessor with two opposite reflectors 460 can be activatedsimultaneously or sequential. If more energy is needed for cleaning andhigh-level disinfection then the two reflectors 461 and 462 areactivated simultaneously, with the risk of some interference in betweenupper and lower shockwaves or pressure waves. If no interference isdesired then the two reflectors 461 and 462 are activated sequential atvery short time intervals.

Utilizing the shockwaves or pressure waves for the cleaning and thedecontamination of the endoscopes 30 or of the reusable contaminatedtubing 30 from respirators, hemodialysis units and any other medicaldevices, is accomplished with a 5 kV-30 kV high voltage per discharge,with frequencies of 1 to 12 Hz (preferable 2 to 10 Hz) and generatingenergies in the targeted area higher than 0.01 mJ/mm 2 and less than 1.5mJ/mm 2). The ultrasound used in the embodiments presented in thisinvention have a frequency in between 10 to 900 kHz, and more preferable30 to 300 kHz. Also, the low-frequency ultrasound utilized in theseinventions operate at 500-1200 Volts (V) peak-to-peak (preferable600-800 V) and power of 5 to 15 Watts (W) (preferable 6 to 12 W). Thedosage of shockwaves/pressure waves and low-frequency ultrasound ischosen in such way to not destroy integrity of delicate materials orcomponents (e.g., fiber optics from the endoscopes, or special valves,etc.). Also, for all embodiments from these inventions an equilibriummust be found in between the input energy, output energy and thepossibility to clean and high-level disinfect the medical instrument orreusable component/part for many cycles using focused acoustic pressureshockwaves 40 or pressure waves (acoustic planar pressure wave 374 orpseudo-planar pressure wave 40 or acoustic radial pressure wave 40) andlow-frequency ultrasound waves 380 and 381, without any damage that canaffect the proper functionality of the medical instrument or reusablecomponent/part.

In all the embodiments presented in these inventions, the focusedacoustic pressure shockwaves 40, or pressure waves (acoustic planarpressure wave 374 or pseudo-planar pressure wave 40 or acoustic radialpressure wave 40), or low-frequency ultrasound waves 380 and 381 can beused in conjunction with biocides that are mixed with the simple fluidsused for cleaning and decontamination, which can enhance even more theireffects on bacteria, viruses, funguses, micro-organisms, or biofilms.

In all embodiments presented in these inventions the decontaminationfluid 205 (see FIGS. 20B and 21B) that fills the endoscope channels 170or the lumen/lumens of the reusable contaminated tubing 30 can bestagnant or continuously circulated during cleaning and high-leveldisinfection process. Either way a pumping system is employed to filldifferent channels and lumens of the endoscopes 30 or reusablecontaminated tubing/tubes 30. This pumping system is not depicted in anyof the figures of these inventions, since such a system is well knownelement and also to achieve a necessary simplicity of the figures, wheremore important elements need to be present and described in detail.

Although, throughout these inventions it was mentioned that the focusedacoustic pressure shockwaves 40 or pressure waves (acoustic planarpressure wave 374 or pseudo-planar pressure wave 40 or acoustic radialpressure wave 40) and low-frequency ultrasound waves 380 and 381 areused to clean and disinfect endoscopes 30 or reusable contaminatedtubing/tubes 30 from ventilators and dialysis machines or from any othermedical devices, it is understood that the same cleaning and high-leveldisinfection methods presented into the embodiments of these inventionscan be applied to any medical one-lumen tubing or multi-lumen tubing ormulti-tubing bundled inside an external sheath that constitute a medicalsystem or a part of a medical device or system that needs reusing andcannot be subject to sterilization process or chemical cleaning anddisinfection that can affect its integrity.

All the membranes from the embodiments of these inventions are made of asoft plastic material that does not scratch the exterior surface of theendoscopes 30 or of the reusable contaminated tubing 30 when in contactwith them. Also, the soft plastic material of the membranes is chosenfrom materials that have acoustic properties very close to the fluidused inside the applicators 97, 201, 256, 261, 310, 360-363, 382,410-413, 420-425, and 462-463 or in the fluid baths 93 to not impedewith the propagation of focused acoustic pressure shockwaves 40 orpressure waves (acoustic planar pressure wave 374 or pseudo-planarpressure wave 40 or acoustic radial pressure wave 40) and low-frequencyultrasound waves 380 and 381.

Various embodiments of the invention have been described. It will,however, be evident that various modifications and changes may be madethereto, and additional embodiments may be implemented, withoutdeparting from the broader scope of the invention as set forth by theclaims. This specification is to be regarded in an illustrative ratherthan a restrictive sense.

What is claimed is:
 1. A system for disinfecting reusableinstrumentation comprising: a first shockwave applicator including afirst opening, wherein the first opening includes a cylindrical,L-shaped or U-shaped membrane, and wherein the first opening isconfigured to receive manual or automatic movement of theinstrumentation through the first opening; a second shockwave applicatorincluding a second opening, wherein the second opening includes acylindrical, L-shaped or U-shaped membrane, and the second opening isconfigured to receive manual or automatic movement of theinstrumentation through the second opening; and a liquid bath in whichthe first opening of the first shockwave applicator and second openingof the second shockwave applicator are linearly aligned for theinstrumentation to simultaneously pass through the first opening andsecond opening.
 2. The system of claim 1, wherein the first shockwaveapplicator includes a full-ellipsoidal reflector.
 3. The system of claim1, wherein the first shockwave applicator includes a semi-ellipsoidalreflector.
 4. The system of claim 1, wherein the first shockwaveapplicator includes a parabolic reflector.
 5. The system of claim 1,wherein the second shockwave applicator is identical to the first shockwave applicator and is rotated from 90° to 180° relative to the firstshock wave applicator.
 6. The system of claim 1, wherein the firstshockwave applicator produces unfocused shockwaves.
 7. The system ofclaim 1, wherein the first shockwave applicator produces focusedshockwaves.
 8. The system of claim 1, wherein the first shockwaveapplicator includes a generator selected from the group consisting ofhydraulic, piezoelectric, laser and electromagnetic.
 9. A system fordisinfecting reusable instrumentation comprising a plurality ofshockwave applicators linearly arranged within a liquid, wherein eachshockwave applicator of the plurality includes an opening having acylindrical, L-shaped or U-shaped membrane, and wherein each opening ofa shockwave applicator is aligned with an opening of an adjacentshockwave applicator for the instrumentation to linearly move and passthrough all openings of the plurality of shockwave applicators.
 10. Thesystem of claim 9 wherein at least one shockwave applicator of theplurality of shockwave applicators includes a full-ellipsoidalreflector.
 11. The system of claim 9, wherein at least one shockwaveapplicator of the plurality of shockwave applicators includes asemi-ellipsoidal reflector.
 12. The system of claim 9, wherein at leastone shockwave applicator of the plurality of shockwave applicatorsincludes a parabolic reflector.
 13. The system of claim 9, wherein atleast two consecutive shockwave applicators of the plurality ofshockwave applicators are rotated from 90° to 180° relative to oneanother.
 14. The system of claim 9, wherein at least one shockwaveapplicator of the plurality of shockwave applicators produces focusedshockwaves.
 15. The system of claim 9, wherein at least one shockwaveapplicator of the plurality of shockwave applicators produces unfocusedshockwaves.
 16. The system of claim 9, wherein at least one shockwaveapplicator of the plurality of shockwave applicators produces planarshockwaves.
 17. The system of claim 9, wherein one or more shockwaveapplicators of the plurality of shockwave applicators has a shockwavegenerator selected from the group consisting of an electrohydraulicgenerator, piezoelectric generator, electromagnetic generator, and lasergenerator.
 18. A method for cleaning reusable instrumentation comprisingmoving the reusable instrumentation through a plurality of openings in aplurality of shockwave applicators arranged linearly in a liquid bath.19. The method of claim 18, wherein each opening of each applicator ofthe plurality of shockwave applicators includes a cylindrical, L-shapedor U-shaped membrane.
 20. An apparatus for cleaning reusableinstrumentation comprising: a first shockwave reflector with a firstshockwave generator; a platform with a top surface defining a top sideof the platform and a bottom surface defining a bottom side of theplatform wherein the first shockwave reflector and first shock wavegenerator are arranged on the top side of the platform; a secondshockwave reflector with a second shockwave generator arranged oppositethe first shockwave reflect and first shockwave generator on the bottomside of the platform; and liquid completely filling the first shockwavereflector and second shockwave reflector that submerges the platform.21. The apparatus of claim 21, wherein the first shockwave reflector andfirst shockwave generator produce focused shockwaves.
 22. The apparatusof claim 22, wherein the second shockwave reflector and second shockwavegenerator produce focused shockwaves.
 23. The apparatus of claim 23,further comprising reusable coiled instrumentation supported on theplatform.
 24. The apparatus of claim 22, further comprising reusablecoiled instrumentation supported on the platform.
 25. The apparatus ofclaim 21, further comprising reusable coiled instrumentation supportedon the platform.